Clinical Trial Manager Virology

Job Title:Clinical Trial Manager - Virology

Location: Stockley Park, UK - Tuesday-Thursday on-site

Contract: 12M

Hours: 37.5 p/w

Pay: Umbrella inside IR35

Please note: this role does not offer any VISA sponsorship, to be eligible for the role you must have the right to work in the UK.

i-pharm consulting is working with a long-term client, they are a research-based biopharmaceutical company that discover, develop, and commercialise innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. They has operations in more than 35 countries world-wide, with headquarters in California, USA and UK head office in Stockley Park.

Description:

The CTM role will involve regional management on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region.

The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. 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.

Essential Duties and Job Functions

• 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
• Under general supervision, is able to examine functional issues from an organizational perspective

Specific Responsibilities:

• Works with Clinical Program Managers to manage regional component of Virology Clinical Trials and/or the entire process of a local Clinical Trial, with the ability to identify issues and adapt to changes.
• Interacts with cross-functional teams internally and externally to ensure trial progress.
• Will incorporate study logistics and planning to accomplish study objectives.
• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.

Knowledge, Experience and Skills

• 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 participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
• Must have a general, functional expertise to support SOP development and implementation

If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call +44020 7551 0802