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Peak Performers · 2 weeks ago

Clinical Trial Manager

Waltham, MA

Contract

Hybrid

Senior Level, Lead/Staff

$125/hr - $125/hr

10+ years exp

Peak Performers has partnered with a global pharmaceutical company to assist in their search for a hybrid Clinical Trial Manager. In this role, you will be responsible for leading operations across all future clinical sites, ensuring that clinical trials are conducted in compliance with regulatory requirements and that the organization’s objectives are met.

Employment

Growth Opportunities

No H1B

Responsibilities

Responsible for developing strategy, and methodology of clinical operations programs

Responsible for ensuring clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready

Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals

Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines

Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers)

Ensures timely execution excellence input into various documents, including asset evidence plan and clinical trial protocols

Responsible for collaborating with the Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable

Drive site selection and subject recruitment programs to deliver study enrollment targets

Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors

Participates in SOP development, process mapping, training of CTAs, and other departmental activities

Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs

Qualification

Clinical OperationsFDA RegulationsICH GuidelinesGCP ComplianceClinical Trial ManagementBudget ManagementPatient RecruitmentProcess ImprovementDocument ManagementTeam Collaboration

Required

M.S or Ph.D in basic sciences with 10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO

Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality

Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required

Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management

Demonstrated experience in successful planning and implementation of clinical trial operations

Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance

Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables