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Senior Clinical Team Manager (Prin.) - Hemonc

8+ years
Not Disclosed
10 Sept. 26, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.