PE Global
Clinical Trial Manager
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Clinical Trials Manager (virology)
PE Global is currently recruiting for a Clinical Trials Manager (virology) for an initial 12 month contract role with a leading multinational Biotech client based in Stockley Park – hybrid.
The candidate will likely work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. The successful candidate will have the ability to work successfully with cross-functional team members globally and to manage stakeholders accordingly.
Job Responsibilities
- Provides regional management of global PIb-III studies managed by Clinical Program Manager
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
- Maintains study timelines
- Contributes to development of study budget
- Contributes to development of RFPs and participates in selection of CROs/vendors.
- Manages CROs/vendors
- Coordinates review of data listings and preparation of interim/final clinical study reports
- May contribute to development of abstracts, presentations, and manuscripts
- Ensures effectiveness of site budget/contract process
- Train CROs/vendors/investigators/study coordinators on study requirements.
- Conducts Monitoring/co-monitoring as required
- Assists in determining the activities to support a project’s priorities within functional area
- Coordinates and supervises all aspects of a clinical study
- May assist Clinical Operations International Therapeutic Area Leads in their duties
- Contributes to Clinical Operations International team activities & initiatives
- Collaborates with local medical affairs colleagues on country specific studies and initiatives
- Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
- May serve as a resource for others within the company for clinical trials management expertise
- Under general supervision, is able to examine functional issues from an organizational perspective
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Requirements
- PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.
- MA / MS with 3+ years’ relevant clinical or related experience in life sciences.
- BA / BS / RN with 3+ years’ relevant clinical or related experience in life sciences.
- Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
- Experience managing the work of external vendors.
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Knowledge & Other Requirements
- Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline
- Previous experience in Virology areas would be advantageous but not essential
- Must have previous study management/coordination experience at Sr CTMA level
- Monitoring experience is highly desirable as co-monitoring will be required
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
- Must be able to generally understand, interpret, and explain protocol requirements to others
- Must be able to prioritize multiple tasks
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
- Excellent teamwork, decision-making and organizational skills are key to success
- Strong communication skills
Interested candidates should submit an up to date CV.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK
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