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Senior Manager, Clinical Operations (FSP )

Thermo Fisher Scientific -
Remote

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Job details

Full-time
11 days ago

Qualifications

English
Research
Performance management
Quality assurance
Bachelor's degree
Staff training
Conflict management
Mentoring
Data entry
Clinical trials
Medical terminology
Communication skills
Negotiation
FDA regulations

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Sr Manager - Clinical Operations – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As a Sr Manager - Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.

What You’ll Do:

Manages staff, providing coaching, mentorship and work direction.
Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.
Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports.
Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables.
Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
Assures adherence to good ethical and regulatory standards.
Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
Participates in process improvement/development initiatives.
Ensures understanding and facilitation of the risk-based monitoring approach.
May provide input into bids and contribute to the procurement of new business where required.
Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.

Works closely with local client/sponsor teams to meet program KPIs and to support in the risk management and resolution of issues.
May lead or contribute to initiatives that enhance the department's performance or lead to process

improvement across the company.

Education and Experience Requirements:

Bachelor Degree in Life Science is Preferred
12+ year of Experience in Clinical Monitoring, Trial Management, eTMF management, Onsite Monitoring related activities
Should have experience in Managing CRAs, CTCs, Project Support Coordinators for More than 4+ Years
Should have experience in managing one or multiple FSP Clients as Single Point of Contact
Should have experience in Workflow Allocation, Performance Management, Quality/CAPA, Reporting related activities
Should be willing to Travel to Clinical Trial Sites across India (up to 25% Travel)

Knowledge, Skills and Abilities:

Advanced mentoring/leadership/supervisory skills
Excellent clinical trials monitoring skills; Remote and on-site
Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
Demonstrated ability to evaluate medical research data
Strong organizational and negotiation skills
Strong attention to detail
Advanced written and oral communication skills
Good knowledge of English language and grammar
Demonstrated use of computer to include data entry, archival and retrieval
Ability to travel as needed
Excellent teammate with team building skills
Excellent interpersonal and conflict resolution skills
Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
Solid knowledge of medical/therapeutic areas and medical terminology

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Apply Now

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