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For your reference, we have included the original job posting below.
Sr Manager, Clinical Operations (Syntonix)
Job Number:
24258806
Company Name:
Biogen Idec
Job Location:
Waltham, MA US
Job Category:
Healthcare & Medical
Sr Manager, Clinical Operations (Syntonix)
Job Title Sr Manager, Clinical Operations (Syntonix) Location US-MA-Waltham Job Category Research & Preclinical Development Requisition Number 12693BR Job Description Oversees activities and provides management and mentoring to the clinical staffs, ensuring adherence to GCP guidelines and attainment of study time lines and milestones. Works with Sr. Director, Clinical Operations, CPLs, CTMs, CTCs, Co-Monitors, and CSSs to ensure conducting successful global clinical studies. Develops, implements, and supports GCO procedures and operational systems, guidelines, and tools to provide increase efficiency in the design, execution and completion of clinical studies.
Responsibilities: Provides day-to-day management and guidance to Clinical Trial Staff (CTMs, CTCs, and CSSs, etc.). Ensures high quality operational performance that is in alignment with therapeutic area and commercial and regulatory strategies and goals. Works with Manager, Clinical Business Analysis to support clinical department financial goals in regards to budget accruals and forecast. Participates in resource planning as appropriate. Works with Managers, Clinical Operations, and the Training Department to establish training curricula and to ensure consistent metrics and performance expectations across studies, therapeutic areas and geographies. Authors and reviews controlled documents (e.g., Standard Operating Procedures, Work Instructions, Charters, etc.), as required. Participates in implementing action plans for improvements through short-term and long-term strategic planning with Global Clinical Operations and across therapeutic areas and functional lines. Lead and/or participates in company wide initiatives or special projects, as assigned. Responsible for overseeing clinical operations Qualifications Min. 8 years experience of clinical research experience with 3-5 years of supervisory or team leader experience.
Excellent problem-solving skills in operations. Ability to handle a high volume of highly complex tasks within a given timeline. Requires strong organizational and leadership skills and ability to prioritize. Must build relationships across and up and down the organization. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. Excellent project management skills, including risk assessment and contingency planning. Requires excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills. Excellent current knowledge of clinical research; monitoring experience desirable. Proven excellence in cross-functional matrix and direct line management of clinical trial personnel. Education Bachelor degree or equivalent experience, preferably in health care or biological science
