Senior Clinical Trial Manager

4 weeks ago

Cape Town, South Africa Int'l AIDS Vaccine Inc. Full time

**Position Description**

**Job Title**:Senior Clinical Trial Manager

**Location**: Cape Town, South Africa, Nairobi, Kenya, or Uganda

**Reports to**: Associate Director, Clinical Operations

**Position Summary**:
Help IAVI translate science into global health impact as a Senior Clinical Trial Manager
IAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who manages, oversees and executes day-to-day operational activities for the conduct of clinical trials according to ICH/GCP guidelines and relevant regulatory guidelines. The Sr. CTM will lead clinical operations of early and late phase and/or highly complex clinical trials, mentor other clinical operations staff, and lead process improvement.

**Key Responsibilities**:

- Develop the Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP.
- Develop study timelines and ensure adherence; Escalates concerns/issues related to timelines to senior management appropriately.
- Lead clinical trial team meetings and contribute clinical updates to cross-functional project team meetings.
- Oversee the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials.
- With oversight from the Associate Director and/or Director, Clinical Operations, develop and control study budgets, working with other departments as appropriate, to ensure execution of studies within budget; escalate concern /issues related to budget management to senior management appropriately.
- Assist the Associate Director, and/or Director, Clinical Operations in determining which services will be conducted by IAVI and which will be outsourced to other vendors, and assists in the identification, evaluation and selection of CROs and other vendors.
- Proactively anticipate risks, and plan for and implement risk mitigation strategies throughout the trial conduct, keeping senior management informed appropriately.
- Actively manage issues that could impact study progress, and take actions or make recommendations to solve issues to support compliance
- Coordinate and assist in developing study protocols.
- Develop Informed Consent Documents, Study Operations Manual, monitoring plan, tracking forms, and other study related documents as required.
- Lead implementation of risk-based monitoring for assigned studies.
- Review and approve monitoring visit reports submitted by CRAs for assigned studies.
- Complete monitoring oversight visits as needed to review clinical data for accuracy and completeness and resolve discrepancies in accordance with the study monitoring plan.
- Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials.
- Mentor and train CRAs and Clinical Trial Associates, Clinical Operations Specialists and Clinical Trial Managers as needed.
- When assigned a trial with a Clinical Operations Specialist (COS), delegate clearly defined clinical trial management activities to the COS and ensure deliverables are met with appropriate timeliness and quality; mentor and provide training to the COS as needed.
- Contribute to the Clinical Development (CD) departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates as well as ensure adherence to regulations/guidelines for GCP.
- Perform other duties as assigned by the manager.

**Education and Work Experience**:

- Bachelor’s degree in a scientific or related field is required; an advanced degree is highly preferred.
- Minimum 7 years relevant experience in clinical trial operations, including 4 years in clinical trial management or equivalent experience at study sponsor or CRO is required.

**Qualifications and Skills**:

- Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations as well as Declaration of Helsinki and relevant country-specific regulations is required.
- Experience in project management, including skills and the ability to deliver on assigned tasks within deadlines is required.
- Experience leading multi-disciplinary clinical trial teams, effectively to deliver clinical trials at high quality, on time and within budget is required.
- Strong interpersonal skills and ability to work effectively with outside vendors, collaborators, subordinates and functional peer groups at various management levels.
- Ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is highly desirable.
- Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
- Being detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities is highly desirable.
- Following all company safety practices,

  • Senior Clinical Trial Manager

    3 weeks ago

    Cape Town, South Africa IAVI Full time

    **Position Description** **Job Title**:Senior Clinical Trial Manager **Location**: Nairobi, Kenya; Cape Town, South Africa; or South Africa-Remote **Reports to**: Director, Clinical Operations **Position Summary**: Help IAVI translate science into global health impact as a Senior Clinical Trial Manager! IAVI is seeking a highly motivated Senior Clinical...

  • Senior Clinical Trial Manager

    4 weeks ago

    Cape Town, South Africa IAVI Full time

    **Position Description** **Job Title**:Senior Clinical Trial Manager **Location**: Cape Town, South Africa; or South Africa-Remote **Reports to**: Associate Director, Clinical Operations **Position Summary**: Help IAVI translate science into global health impact as a Senior Clinical Trial Manager! IAVI is seeking a highly motivated Senior Clinical Trial...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa IAVI Full time

    Position DescriptionJob Title:Senior Clinical Trial ManagerLocation: Cape Town, South Africa; or South Africa-RemoteReports to: Associate Director, Clinical OperationsPosition Summary:Help IAVI translate science into global health impact as a Senior Clinical Trial ManagerIAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who will manage,...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa IAVI Full time

    Position DescriptionJob Title:Senior Clinical Trial ManagerLocation: Nairobi, Kenya; Cape Town, South Africa; or South Africa-RemoteReports to: Director, Clinical OperationsPosition Summary:Help IAVI translate science into global health impact as a Senior Clinical Trial ManagerIAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who...

  • Clinical Trials Unit Manager

    4 weeks ago

    City of Cape Town, Western Cape, South Africa Desmond Tutu HIV Foundation Full time

    **Overview**: **Reference** DTHF/C025 **Salary** not applicable **Job Location**: - South Africa - City of Cape Town **Job Type** Permanent **Posted** Friday, April 12, 2024 **Closing date** 26 Apr 2024 23:59 **CLINICAL TRIALS UNIT MANAGER** **PERMANENT** **J52, GROOTE SCHUUR, OBSERVATORY (ON-SITE)** **The Desmond Tutu Health Foundation (DTHF) is a...

  • Clinical Trial Programme Manager

    4 weeks ago

    Cape Town, South Africa SubjectWell Full time

    **About SubjectWell** SubjectWell is a private equity-owned company on an unstoppable mission to disrupt the antiquated $100 billion dollar clinical trial patient recruitment sector. Almost all clinical trials fall behind schedule, leaving patients unable to access the most promising treatments and pharmaceutical and biotech companies unable to quickly carry...

  • Clinical Trials Unit Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa Desmond Tutu HIV Foundation Full time

    Overview:ReferenceDTHF/C025Salarynot applicableJob Location: South Africa City of Cape TownJob TypePermanentPostedFriday, April 12, 2024Closing date26 Apr :59CLINICAL TRIALS UNIT MANAGERPERMANENTJ52, GROOTE SCHUUR, OBSERVATORY (ON-SITE)The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in...

  • Clinical Trial Investigator

    2 weeks ago

    Cape Town, South Africa TREAD Research (PTY) LTD Full time

    Seeking clinical trial investigator to provide comprehensive medical care/clinical support to participants enrolled into clinical trials at TREAD Research Clinical Trial experience will be advantageous. Open to work half-day. **Key Performance areas**: - Provision of clinical care to patients and participants - Accurate and comprehensive medical record...

  • Clinical Trial Recruiter

    4 weeks ago

    Cape Town, South Africa SubjectWell Full time

    **About SubjectWell**: SubjectWell is a venture-backed technology startup on an unstoppable mission to disrupt patient recruitment for clinical trials, a $100 billion dollar sector. Clinical trials need millions of qualified patient volunteers, but regularly fall behind schedule because patients are unaware of the benefits of clinical trials or even how to...

  • Clinical Trial Investigator

    2 weeks ago

    Cape Town, Western Cape, South Africa TREAD Research (PTY) LTD Full time

    Seeking clinical trial investigator to provide comprehensive medical care/clinical support to participants enrolled into clinical trials at TREAD ResearchClinical Trial experience will be advantageous.Open to work half-day.Key Performance areas: Provision of clinical care to patients and participants Accurate and comprehensive medical record keeping Clinical...

  • Clinical Trial Quality Assurance Manager

    4 weeks ago

    Cape Town, South Africa TASK Full time

    **Overall Purpose of the Position**: As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies....

  • Clinical Trial Recruiter

    5 days ago

    Cape Town, South Africa SubjectWell, Inc Full time

    **About SubjectWell** SubjectWell is a venture-backed technology startup on an unstoppable mission to disrupt patient recruitment for clinical trials (a $100 billion dollar sector) and connect market-ready treatments to the patients who need them. Clinical trials need millions of qualified patient volunteers but regularly fall behind schedule because...

  • Clinical Trial Quality Assurance Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies. You...

  • Clinical Trial Regulatory Manager

    3 weeks ago

    Cape Town, South Africa TREAD Research (PTY) LTD Full time

    Clinical Trial Regulatory Manager with at least 2 years of experience. Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs. RESPONSIBILITIES - Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa SubjectWell, Inc Full time

    About the positionThis Call Centre position is for medical graduates who will be responsible for contacting Spanish speaking patients around the world who have particular health conditions and are interested in participating in clinical trials.Responsibilities and Duties Calling patients who have asked for more information in clinical trials and conducting a...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa SubjectWell, Inc Full time

    About SubjectWellSubjectWell is a venture-backed technology startup on an unstoppable mission to disrupt patient recruitment for clinical trials (a $100 billion dollar sector) and connect market-ready treatments to the patients who need them. Clinical trials need millions of qualified patient volunteers but regularly fall behind schedule because patients are...

  • Clinical Trial Recruiter

    4 weeks ago

    Cape Town, South Africa TASK Full time

    **About the Company**: TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas. **Overall Purpose of the...

  • Clinical Trial Quality Assurance Officer

    2 weeks ago

    Cape Town, South Africa TASK Full time

    **About the Company**: TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas. **Overall Purpose of the Position**: As...

  • Clinical Trial Quality Assurance Officer

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:As a Clinical...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:The position,...