Exciting Contract Opportunity for a Clinical Trials Manager with one of the Top Pharma clients.
Title: Clinical Trials Manager
Duration: 12 month contract
Location: Stockley Park (3 out of 5 days required onsite)
The CTM role will involve regional management on 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 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
- Some International travel is required.
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 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