Clinical Research Manager
Req #: 17001345
Job Category: Clinical Development
Work Location: Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DB
Organization: Celgene UK Marketing LTD
Shift: Day Job
Employee Status: Regular
Job Type: Experienced
Job Level: Manager with Direct Reports
Travel: Yes, 50 % of the Time
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Clinical Research Manger will support the execution of high quality clinical research by managing the Celgene Clinical Operations team, partnering and relationship management with Clinical Research Organisations at a local country level including CRO oversight.
They will also support the study teams as required, working cross-functionally with applicable local teams and departments.
The role will include travel which may be up to 50%. Overnight stays may be required.
Role and Responsibilities
- Support the local/regional planning and execution of Celgene-sponsored clinical trials (phases I-IV).
- Have a comprehensive overview of all Celgene sponsored clinical study activities in the country / region.
- Support the feasibility process for clinical programs and studies in collaboration with Clinical Operations and CRO partners, as appropriate.
- Proactively collaborate with CROs, and Study Teams for the execution of clinical trials.
- Coordinate, plan, attend and participate/present at local investigator meetings as appropriate.
- Collaborate with local Medical Affairs to ensure clinical support and regional activities are in alignment with corporate objectives, as appropriate.
- Keep informed on relevant local regulations and law and communicate to applicable personnel, as appropriate:
- Ensure appropriate personnel have comprehensive knowledge of relevant local regulations and laws including any amendments, as required.
- For in-sourced studies (as applicable):
- Ensure allocated studies are monitored and conducted according to protocol, SOPs/WPs and regulations (e.g. GCP/ICH, local regulations) by coordinating and supervising country CRA and CTA, activities in order to ensure high quality research, timelines and expected study objectives are met.
- Manage resource utilization and track local associated trial budgets (at local level)
- Manage / supervise EC/IRB/HA submissions / correspondence and any other local requirements to support clinical as applicable
- Ensure compliance with timelines as per SOPs/Study Monitoring plan and with SOPs/ GWPs, guidance documents and Study Monitoring Plan.
- Ensure relevant study data are updated in a timely manner in CTMS or in other tracking system
- Perform assessment visits with CRAs on assigned projects and serve as a mentor for new and junior CRAs.
- For Outsourced Studies. To maintain and optimize CRO relationship, communication and oversight (including problem solving).
- May act as a CRA for some sites or back-up CRA, if necessary.
- Perform line management activities ; if applicable, hire and mentor Clinical Operations personnel, conduct performance reviews and ensure personal and professional growth of personnel.
- Ensure training of Clinical Operations personnel on local Celgene SOPs and WPs.
- Manage the local Clinical Operations personnel to assure adherence to ICH/GCP, SOPs, WPs and local regulations.
- Perform other duties as assigned by local and central management.
- Scientific / healthcare related degree, preferred.
- Extensive experience in the (international) pharmaceutical / medical field with solid clinical trial management / monitoring experience, mandatory.
- Any relevant therapeutic area experience will be considered. Haemartology / Oncology experience is desirable.
- Line-management experience desirable.
Skills and Knowledge required
- Excellent knowledge of regulations that apply to clinical studies.
- Strong leadership skills essential.
- Effective team building and teamwork skills.
- Ability to prioritize and manage time efficiently.
- Excellent written and verbal communication and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
- Working knowledge of SOPs/regulations relevant to clinical research.
- Fluent in written and spoken English.
- Computer literate; familiarity with Microsoft Office programs, in particular, Word and Excel.
- Financial and business awareness.