Site Management Franchise Lead (CNS), Manager/Senior Manager, Clinical Operations, Europe (Remote)

Worldwide Clinical Trials ,
Nottingham, Nottinghamshire
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Job Description

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). RESPONSIBILITIES: 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. REQUIREMENTS: * 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 associateOR * Equivalent education/training and ten years clinical research experience as a clinical research associate * Two years more management experience * Travel required * Passport required #L1-JM1 INDJM1

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