Late-stage experience in CNS therapeutic area (Phases 3 and 4 experience)
Strong PM experience
Soft Skills
The Clinical Manager Tasks Include
Plans , executes, and completes clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Client SOPs, within agreed-upon timeframes and budget.
Provides oversight and project management of clinical studies at Client, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Client SOPs
Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)
Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Client departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
Participate in forecasting study expenditures and resourcing needs.
Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast!
Provide timely communication of any variances in budget forecast to the Clinical Department Head
Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
Manage recruitment efforts and activities to meet study enrolment goals and timelines.
Qualifications/Experience
8+ years related experience in the pharmaceutical/biotechnology industry, including 2+ years of management experience.
3+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in the CNS therapeutic area
Experience in management of international or global clinical trials is preferred.
Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; master’s degree preferred
Required Skills Include
Strong project management skills
Experience in clinical site monitoring is preferred
Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
Experience in protocol development/writing is preferred
Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I-IV, start-up through closeout), scientific methods, research design, regulatory compliance, and clinical data management
Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members
Ability to work effectively within a team matrix as well as independently
Financial management skills as applicable to oversee project expenditures
Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Health Care Provider
Industries
Staffing and Recruiting
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