Background information about the job or company (e.g., role context, company overview)

The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.

Responsibilities or duties

Clinical Operations:

Manage clinical vendors (including on-site monitors / CRO) and oversee relevant sections of the Protocol Management Plan. Responsibilities include, but are not limited to the following activities:

• Lead point of contact for clinical vendors
• Support vendor selection and contracting
• Train vendors
• Monitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits.
• Track vendor invoices for accuracy and against contract and send invoices for processing and payment.
• Provide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities.
• Conduct risk planning and mitigation for vendors and clinical activities working with CTMs (Clinical Trial Managers) to mitigate risks and solve issues.
• Review, provide input, and draft assigned sections of key study documents.
• Ensure approved monitoring plan is in place.
• Develop quality oversight plan for monitoring activities.
• Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget.
• Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, while ensuring TMF is inspection ready.
• Work with CTM and other departments to oversee data quality through various means including data listings reviews.
• Prepare for and conduct site visits as needed, including site qualification, study initiation and Quality Oversite visits.
• Provide study status updates to project team and management as needed.
• Act as clinical operational lead on observational studies as assigned.
• Oversee studies that IAVI monitors for other sponsors.

Departmental and knowledge development activities:

• Participate in/initiate Clinical Development departmental activities as assigned (e.g., drafting/reviewing operational procedures, participating in departmental meetings, etc.)
• Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
• Remain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local/international regulatory and ethical guidelines and requirements.
• Remain abreast of scientific knowledge of targeted disease and population and investigational product(s).
• Participate in training activities for new staff, as needed.
• Perform other duties as assigned.

Qualifications or requirements (e.g., education, skills)

Education and Work Experience:

• Bachelor’s degree in a scientific or related field is required.
• Minimum 4 years of clinical trials experience including clinical monitoring experience is required; Minimum of 6 years’ clinical trial experience required for Senior COS.
• Clinical team lead experience is preferred for COS; Clinical Team Lead experience is required for Senior COS.

Qualifications and Skills:

• Experience conducting presentations of technical information concerning specific projects is required.
• Interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally is required.
• Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
• Project planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
• Excellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country specific regulations are required.
• Excellent oral and written communication skills are required.
• Proven ability to coordinate and lead multi-disciplinary project teams is required.
• A professional demeanor, as well as a pleasant manner and positive “can-do” attitude.
• Flexible and adaptable to accommodate changing deadlines to meet organizational needs is required.
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• Ability to travel up to a maximum of 50% of the time occasionally is required.
• High level of independence in performing responsibilities is highly desirable.
• Ability to mentor other staff including Clinical Trial Associates and Clinical Research Associates is highly desirable.
• Familiarity with emerging infectious diseases and managing trials in West Africa.

• Lead point of contact for clinical vendors
• Support vendor selection and contracting
• Train vendors
• Monitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits.
• Track vendor invoices for accuracy and against contract and send invoices for processing and payment.
• Provide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities.
• Conduct risk planning and mitigation for vendors and clinical activities working with CTMs (Clinical Trial Managers) to mitigate risks and solve issues.
• Review, provide input, and draft assigned sections of key study documents.
• Ensure approved monitoring plan is in place.
• Develop quality oversight plan for monitoring activities.
• Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget.
• Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, while ensuring TMF is inspection ready.
• Work with CTM and other departments to oversee data quality through various means including data listings reviews.
• Prepare for and conduct site visits as needed, including site qualification, study initiation and Quality Oversite visits.
• Provide study status updates to project team and management as needed.
• Act as clinical operational lead on observational studies as assigned.
• Oversee studies that IAVI monitors for other sponsors.
• Participate in/initiate Clinical Development departmental activities as assigned (e.g., drafting/reviewing operational procedures, participating in departmental meetings, etc.)
• Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
• Remain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local/international regulatory and ethical guidelines and requirements.
• Remain abreast of scientific knowledge of targeted disease and population and investigational product(s).
• Participate in training activities for new staff, as needed.
• Perform other duties as assigned.

• Experience conducting presentations of technical information concerning specific projects is required.
• Interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally is required.
• Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
• Project planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
• Excellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country specific regulations are required.
• Excellent oral and written communication skills are required.
• Proven ability to coordinate and lead multi-disciplinary project teams is required.
• A professional demeanor, as well as a pleasant manner and positive “can-do” attitude.
• Flexible and adaptable to accommodate changing deadlines to meet organizational needs is required.
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• Ability to travel up to a maximum of 50% of the time occasionally is required.
• High level of independence in performing responsibilities is highly desirable.
• Ability to mentor other staff including Clinical Trial Associates and Clinical Research Associates is highly desirable.
• Familiarity with emerging infectious diseases and managing trials in West Africa.

• Bachelor’s degree in a scientific or related field is required.
• Minimum 4 years of clinical trials experience including clinical monitoring experience is required; Minimum of 6 years’ clinical trial experience required for Senior COS.
• Clinical team lead experience is preferred for COS; Clinical Team Lead experience is required for Senior COS.