Senior Manager, Clinical Research

Biotechnology and Pharmaceutical Senior Manager, Clinical Research Job Description:General Summary:Candidate provides global leadership to execute large scale and/or complex clinical programs for assigned therapeutic area. Through their efforts, enables the design and execution of multiple high quality clinical studies to ensure safety and effectiveness of BSC products. Manages many clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, field clinical monitors, senior Clinical Sciences management, medical directors, functional management, and acts as BSC liaison with investigators and clinical site staff. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.Duties and Responsibilities: Responsible and accountable for several concurrent global clinical studies as part of a therapeutic program product strategy Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables Hires, trains, develop, mentors, and supervise project managers and other clinical staff. Develops staffing plans for therapeutic area or region. Participates in and assists in the development of global clinical strategies for assigned therapeutic area(s) working in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and regions to obtain approvals by the most effective method possible. Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region. Prepares and manages budgets for projects in therapeutic area. Negotiates contracts and budgets with sites and vendors. Reviews and approves protocols for projects; reviews final study conduct documents such as study manuals, study tools, etc. Prepares investigational site lists and participates in reviewing and approving investigational sites. Participates in site selection committee and drives final selection. Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves IVRS specifications. Drafts, reviews, and approves instructions for use for investigational devices. Attends investigator and coordinator meetings, representing the therapeutic area or region. Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies. Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees. Reviews and approves trigger plans for CEC and DMC. Manages data release and review meetings for projects in therapeutic area; reviews and participates in finalizing and approving final manuscript or final reports for projects. Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate. Reviews and approves Clinical Risk Benefit Analyses. Reviews and approves corrective action plans at individual sites and across study. May participate in internal/external study-related audits. Develops and maintains Clinical Sciences infrastructure such as the drafting and/or reviewing of SOPs, DOPs, and Work Instructions. Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.Minimum Education & Experience:Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. PhD-level degree (or equivalent), or qualification in medicine preferred. 8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials is preferred.Working Conditions:General office environment, approximately 50% travel to research laboratory or hospitalJob Experience:Minimum Education & Experience:Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. PhD-level degree (or equivalent), or qualification in medicine preferred. 8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 3+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials is preferred.Minimum Education Required: DoctoralYears of Experience Required: More than 5 yearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.