Job Description


Join our pioneering team at Thermo Fisher Scientific, where your work contributes to a grand mission: enabling our customers across the globe to make the world healthier, cleaner, and safer.
As the Executive Assistant, you will play a critical role in supporting our executive team and ensuring the smooth operation of our office. You will be the backbone of daily operations,... providing key administrative support and coordinating office activities to facilitate efficient workflows and contribute to our mission!
Your role will encompass a range of responsibilities from managing executive schedules to ensuring our office environment is organized and responsive to the needs of our team. As the central point of coordination, you will enable our leaders to focus on strategic objectives by efficiently managing their administrative tasks.


Key Responsibilities:

In this role, based in Johannesburg, South Africa, your primary responsibilities will include:


Provide comprehensive administrative support to the executive team, including calendar management, meeting coordination, and travel arrangements.
Serve as the first point of contact for internal and external stakeholders seeking to connect with the executive team.
Coordinate office operations, ensuring a well-organized and effective working environment, including managing office supplies and liaising with facility management.
Implement office policies that promote company culture and vision, as well as managing office budgets.
Coordinate with HR and other departments to ensure smooth operations and facilitate communication across teams.
Plan and execute company events, meetings, and conferences, ensuring they align with corporate objectives and are executed flawlessly.
Lead special projects and initiatives as directed by the executive team, contributing to the strategic objectives of the MEA operations.


Minimum Requirements/Qualifications:


Bachelor's degree in Business Administration, Management, or a relevant field.
Proven experience as an executive assistant, office manager, or similar role, preferably within a multinational corporation.
Exceptional organizational skills with the ability to multitask and prioritize work effectively.
Strong communication skills, both written and verbal, and the ability to interact professionally with all levels of the organization. Fluency in English is essential.
High level of discretion and confidentiality.
Proficiency with Microsoft Office Suite and experience with virtual communication platforms.
High proficiency in project management. more

Role Overview


Manages full supply chain oversight for complex global clinical trials. Ensures project/study activities are in compliance with company and client requirements.. Acts as a department representative on all assigned projects and provides consultation services to clients. 


A day in the life:


Develops study specific plans for each assigned project. 
Meets with internal... teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets. 
Integrates all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements. 
Participates in ongoing training on new regulations. 
Represents the department internally and externally at meetings, strategic projects and initiatives as per the business requirements. 
Mentors and guides supports junior team members. 
Participates in process improvement initiatives. 
Maintains and uses existing tools while continously looking for improvement opportunities
May participate in the bidding and/or bid defense opportunities
Client contact for their supply chain strategy/requests/questions/concerns Participates in ongoing training on new regulations


Education and Experience: 


Bachelor's degree or equivalent and relevant formal academic / vocational qualification 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 (PM) 8+ (SrPM) years). Preferably eith experience of clinical supplies in a clinical trial environment.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 


Knowledge, Skills and Abilities: 


Excellent English and communication skills both written and verbal
Excellent interpersonal, planning, organizational, problem solving, sense of urgency and decision making skills.
Demonstrated leadership and team building skills
Strong working knowledge of Microsoft Office suite
In-depth focus on customers and attention to detail
Ability to work in team environment, as well as work completely independent
Comprehensive understanding of clinical supply operation
Strong client building and 3rd party relationship management
Outstanding ability to provide customer service with the highest standards of quality and excellence
Skillful in bid preparation and bid defense more

Role overview


Supports supply chain for global clinical trials. Ensures project/study activities are in compliance with company and client requirements.


A day in the life


Develops study specific plans for each assigned project.
Meets with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets.
Ensures fluent... communication and interaction between internal departments in order to avoid obstacles during the course of the study.
Integrates all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements.
Participates in ongoing training on new regulations


Education and Experience:


Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.


Knowledge, Skills and Abilities:


We require experience working in a clinical trial environment with clinical supplies.
Good English and communication skills both written and verbal
Strong interpersonal, planning, organizational, problem solving, sense of urgency and decision making skills
Demonstrated effective leadership and team building skills
Strong working knowledge of Microsoft Office suite
Strong focus on customers and attention to detail
Ability to work in team environment, as well as work independently with moderate guidance
Basic understanding of clinical supply operations more

What will you do?


Coordinating technical and service aspects of a given project, ensuring compliance with study requirements, ensure day to day operational study requirements are met
Managing logistics for importation and delivery of investigational medicinal products
Provide training to team members and stakeholders
Participating in internal and external meetings
Maintaining... compliance with established procedures and standards
Contributing to corporate goals
Assisting in the investigation of non-conformances and customer complaints
Liaising with global project managers or clients on drug returns and destruction requirements
Timely provision of reports
Design, implementation, maintenance and reporting of key performance indicators
Continuous improvement and self-training on the quality management system
Maintain the quality adherence through all processes
Communication with clients and global project managers


How will you get here? Education


Grade 12 or equivalent
Project Management experience will be beneficial
Any co-ordinational experience will be an advantage
Excel intermediate level
Clinical trial industry experience will be an advantage


Knowledge, Skills, Abilities:


Effective time management and prioritization skills Self-driven and motivated
Ability to work independently and be self-motivated with a positive attitude
Collaborate cross departmental and cross organizational
Customer focused
Detailed orientated
Financially orientated
Ability to work under pressure and meet tight deadlines
Strong excel capabilities more

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. Government, FSO, FSP, etc.). Acts as a site processes specialist, ensuring that the trial... is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.
Documents observations in reports and letters using approved business writing standards.
Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required. more

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. Government, FSO, FSP, etc.). Acts as a site processes specialist, ensuring that the trial... is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.
Documents observations in reports and letters using approved business writing standards.
Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required. more

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. Government, FSO, FSP, etc.). Acts as a site processes specialist, ensuring that the trial... is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required. more

The Warehouse Pharmacist supervises protecting product integrity and following wholesale and regulatory guidelines. This position requires the candidate to work independently, complete assigned tasks, and manage risks.

A day in the Life:

Perform delegated functions and activities of the Responsible Pharmacist during their absence.
Deliver high standards of pharmaceutical care for the... end-to-end management of dispensary operations in accordance with Good Pharmacy Practice and Good Wholesale Practice.
Assist in maintaining pharmacy plans, Standard Operating Procedures (SOPs), and other relevant documentation required by law.
Participate in and contribute to the development and achievement of the company goals and objectives.
Demonstrate and promote the company vision of the 4I's: Integrity, Intensity, Innovation, and Involvement.
Dispense study-related drugs according to project-specific protocols and SOPs.
Handle scheduled substances and ensure legal requirements regarding the documentation and control of scheduled medicines are strictly adhered to. This includes ensuring that scheduled substances are not accessed by unauthorized individuals.
Ensuring the safe and effective storage and keeping of scheduled substances in the pharmacy under direct supervision.
Act as a back-up Site Controlled Substance Responsible Person Pharmacist in the absence of the Responsible Pharmacist.
Coordinate logistics activities to ensure clinical supplies are received, stored, and distributed following approved procedures, policies, and regulatory requirements.
Manage and control returns, quarantine, destruction, expired stock, and batch recalls.
Supervise drug storage conditions and record-keeping.
Ensure 100% drug accountability and compliance with randomization codes as per study-specific procedures.
Ensure that required environmental conditions are continually met.
Perform departmental self-inspections.

Keys to Success:

Education

B.Pharm degree
Registered with SAPC

Experience

Experience in a Warehousing environment will be advantageous
Proven track record in accurately performing pharmacist responsibilities
Experience with Good Pharmacy Practice and Good Wholesale Practice

Knowledge, Skills, Abilities

High attention to detail
Self-motivated
High level of accuracy
Strong organizational and multitasking abilities
Excellent communication skills

Physical Requirements / Work Environment

Ability to work in a warehouse environment
Capable of lifting and moving pharmaceutical supplies
Standing for extended periods more

Position Overview:

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. Government, FSO, FSP, etc.). Acts as a site processes specialist,... ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Duties and Responsibilities:

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters using approved business writing standards. Raises observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.

Education:

Bachelor's degree in a life sciences field.
Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2-3 yrs) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills & Abilities:

Basic medical/therapeutic area knowledge and understanding of medical terminology.
Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
Good oral and written communication skills, with ability to communicate effectively with medical personnel.
Good interpersonal skills.
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
Good organizational and time management skills.
Ability to remain flexible and adaptable in a wide range of scenarios.
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
Ability to manage Risk Based Monitoring concepts and processes.
Ability to work in a team or independently as required.
Good digital literacy: proven knowledge of Microsoft Office and ability to learn appropriate software.
Good English language and grammar skills.
Flexibility to travel in-country and to other countries within Africa. more

Discover Impactful Work:

This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and... contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.
This person may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.

A day in the Life:

Provides medical content and leadership of the clinical studies
Medical Monitoring of clinical studies
Establish and approve scientific methods underlying the design and implementation of clinical protocols
Ensure study subject safety
Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
Collaborate with the study executive and independent safety committee when needed
Represent clinical research through membership on trial teams.
Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
Collaborate with leading academic medical centers
Recruit, guide and motivate clinical investigators
Ensure study compliance by understanding and applying all relevant SOPs and GCPs
Participate in long range strategic planning

Education

MD degree with specialization in Psychiatry/ Neurology is mandatory
Drug Development experience in the area of Psychiatry/ Neurology
Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.

Knowledge, Skills, Abilities

Demonstration and commitment to vigilant proactive problem solving
Excellent leadership abilities
Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
Previous experience with regulatory submissions.
Excellent written and verbal communication skills.
Ability to travel. more