Clinical Trial Manager

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 (3 days in the office).

Daily rate is £351.35 PAYE or £466.60 via an umbrella company

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

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.

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
• 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*