Senior Manager, Clinical Operations (FSP)
By Admin · Clinical Research & Clinical Operations
ROLE OVERVIEW
Senior clinical operations leadership role responsible for managing clinical operations staff, FSP client relationships, resource allocation, performance management, quality, training and operational delivery across clinical trials.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage and coach clinical operations staff
- •conduct performance appraisals and career development discussions
- •recruit and onboard clinical operations employees
- •support resource allocation and project operational delivery
- •deliver training on SOPs, WPDs and clinical operations requirements
- •ensure adherence to ethical and regulatory standards
- •monitor quality issues and support QA audits
- •review Activate, CTMS, Preclarus and Clarity metrics and KPIs
- •evaluate employee monitoring and project execution through PAVs
- •support risk-based monitoring and process improvement
- •manage FSP client relationships and program KPIs
- •contribute to business development and strategic planning
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Science preferred
- 12+ years of experience in clinical monitoring, trial management, eTMF management or onsite monitoring activities
- 4+ years managing CRAs, CTCs or Project Support Coordinators
- experience managing one or multiple FSP clients as single point of contact
- experience in workflow allocation, performance management, quality/CAPA and reporting
- willingness to travel to clinical trial sites across India up to 25%
PREFERRED QUALIFICATIONS
- •Strong advanced mentoring, leadership and supervisory capability
- •advanced clinical trial monitoring knowledge
- •experience with remote and onsite monitoring
- •knowledge of ICH-GCP and FDA guidelines
- •medical research data evaluation
- •strong organizational, negotiation and communication skills
- •knowledge of medical/therapeutic areas and medical terminology
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global scientific services and life sciences company. Its PPD clinical research organization supports pharmaceutical and biotechnology companies in clinical development, with the supplied posting noting support for the top 50 pharmaceutical companies and more than 750 biotechs across 2,700 clinical trials in 100+ countries over the previous five years.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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