Site Management Franchise Lead (CNS), Manager/Senior Manager, Clinical Operations, Europe (Remote)
Location: Nottingham, England, United Kingdom
Requisition Number: 615
Position Title: Manager, Clinical Operations Site Management (Franchise Lead)
SUMMARY: Responsible for providing on time and quality delivery of site management services from assigned Clinical Research Associates within assigned therapeutic area(s) and program(s).
Tasks may include but are not limited to:
- Provide therapeutic and operational expertise throughout the program/project delivery lifecycle
- Ensure that projects within the Franchise are properly resourced
- Responsible for creating-collaborating with Therapeutic team to provide effective delivery strategies and solutions for Franchise projects and programs
- Act as main contact person for the Project management Franchise Lead
- Present at Proposal Defense/client meetings as needed to support new or ongoing business
- Ensure CRAs are trained on project specifics
- Ensure LCRAs are trained to support the clinical scope of work (which includes SOP review, QI/CAPA understanding, Clinical Monitoring Plan)
- Coordinate and collaborate, with WCT Global Quality Assurance, to provide training opportunities identified in CAPA information
- Manage the quality of assigned staff's clinical work
- Coordinate efforts between the Project Management, Site Management, and Study Start Up
- Establishing regular communication to include quality metric (SVR compliance, SDV metrics, on site metric discussion, etc.) and overall “health” of the projects (data query status, managing to the SOW, resource status)
- Conduct appraisal performance review for direct reports
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Broad protocol knowledge; therapeutic knowledge desired
- Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery
- Innovative and strategic thinker.
- Superior oral and written communication skills.
- Strong planning and organizational skills.
- Good interpersonal skills.
- Experienced problem solving/decision making skills.
- Good attention to detail.
- Understanding of clinical research principles and process, data collection and editing skills.
- Ability to navigate in EDC software (InForm, Medidata, etc.)
- Strong knowledge of FDA regulations, ICH Guidelines and HIPAA.
- Understanding of standard operating procedures.
- Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and eight years clinical research experience as a clinical research associate OR
- Equivalent education/training and ten years clinical research experience as a clinical research associate
- Two years more management experience
- Travel required
- Passport required
State: Greater London
Employment Type: Regular
Community / Marketing Title: Site Management Franchise Lead (CNS), Manager/Senior Manager, Clinical Operations, Europe (Remote)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Nottingham, GB