Job Title: Senior Clinical Team Manager (Principal) – Hematology/Oncology
Location: Remote, North Carolina, United States of America
Job Type: Full-time
Job Category: Clinical Research
Remote/Onsite: Fully Remote
Job Id: R-01327955
Company Overview:
Thermo Fisher Scientific’s Clinical Research Services team (PPD®) delivers cutting-edge scientific and clinical expertise to advance the development of life-changing therapies. The team focuses on global clinical trials, providing operational excellence and ensuring regulatory compliance.
Work Schedule:
Standard (Monday–Friday)
Environmental Conditions:
Office-based
Some remote work flexibility
Occasional independent travel up to 20% (air, train, automobile)
Job Summary:
The Senior/Principal Clinical Team Manager (CTM) is responsible for leading clinical teams, ensuring delivery of high-quality clinical trial data, and managing operational and regulatory aspects of Hematology/Oncology studies. The role combines therapeutic expertise, leadership, and project management to ensure trials are conducted efficiently, on-time, and within budget.
Key Deliverable:
Achieve final clinical deliverables (e.g., clean data from evaluable patients) within contractual timelines, ensuring quality, compliance, and cost-effectiveness.
Key Responsibilities:
Clinical Leadership & Team Management:
Lead all clinical operational and quality aspects of assigned studies.
Manage, mentor, and train junior staff and clinical team members.
Coordinate Clinical Management members across regions or countries.
Ensure clinical activity is conducted within scope, timelines, and budget.
Project & Protocol Management:
Collaborate with Project Manager to implement training, tracking, and quality systems.
Develop and optimize clinical tools (Monitoring Plan, Guidelines, Master Action Plan).
Support Trial Master File setup, CRF design, and regulatory documentation.
Monitor clinical trial progress, review monitoring visit reports, and resolve queries.
Ensure regulatory compliance and timely submissions, including ethics committee follow-ups.
Cross-functional Collaboration:
Work with other departments to meet project deliverables.
Communicate effectively with study sites regarding protocol, participation, and CRF completion.
Contribute to process improvements and best practices.
Financial & Resource Management:
Monitor project budgets and clinical resource allocation.
Provide input on forecast estimates for clinical activities.
Adjust resources and team workload based on project needs.
Education & Experience:
Required:
Bachelor’s degree or equivalent in life sciences, medicine, or related field.
8+ years of clinical research experience, with exposure to global clinical team leadership.
Preferred:
Advanced degree in life sciences, medicine, or related field.
Experience in Hematology/Oncology clinical trials.
Therapeutic knowledge in Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head & Neck, Pancreas, Prostate, NSCLC, Breast, Colorectal, Radiopharmaceutical, Cell & Gene Therapy, or CAR-T trials.
Knowledge, Skills & Abilities:
Strong leadership, mentorship, and team motivation skills.
Effective planning, organizational, and multi-project management capabilities.
Proficiency in change management and process improvement.
Knowledge of ICH/GCP, FDA guidelines, and clinical monitoring practices.
Strong problem-solving, decision-making, and risk management skills.
Excellent oral and written communication skills.
Financial competence: budgeting, forecasting, and fiscal management.
Proficient in Microsoft Office and automated systems for clinical operations.
Ability to independently lead clinical-only studies.
Working Environment:
Office-based with remote flexibility.
Exposure to potentially hazardous elements typical of healthcare or lab environments.
Ability to communicate effectively with diverse teams.
Work under pressure while handling multiple projects.
Upright and stationary for extended periods; may include travel.
Company Values:
Integrity – Innovation – Intensity – Involvement
Commitment to advancing safe and effective therapeutics globally.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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