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Senior Clinical Team Manager (Prin.) - Hemonc

8+ years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time 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

Senior Clinical Team Manager (Principal) – Hematology & Oncology

Fully Remote – North Carolina, USA**
Job ID: R-01327955 | Category: Clinical Research | Employment Type: Full-Time

Overview

Join one of the world’s leading Contract Research Organizations (CROs) supporting the PPD® clinical research portfolio under Thermo Fisher Scientific. As a Senior/Principal Clinical Team Manager (CTM), you will play a critical role in advancing global clinical trials across hematology and oncology, ensuring the successful execution of high-impact research programs.

This position is fully remote and requires strong therapeutic expertise, operational leadership, and the ability to manage complex, multi-regional clinical programs.


Role Summary

The Senior/Principal Clinical Team Manager is accountable for delivering final clinical outputs—including high-quality, evaluable patient data—within agreed timelines, budgets, and contractual expectations. The role involves leading regional or global clinical teams, directing operational activities, ensuring protocol adherence, and maintaining regulatory compliance across assigned studies.

You will collaborate closely with Project Managers and cross-functional departments, acting as the primary clinical operations leader responsible for study oversight and team performance.


Key Responsibilities

Clinical Operations Leadership

  • Lead all clinical operational and quality aspects of assigned studies of moderate to high complexity.

  • Serve as Regional Lead CTM or Clinical Study Manager as needed.

  • Develop clinical tools, including Monitoring Plans, Guidelines, and Data Quality–aligned documents.

  • Oversee the setup, organization, and quality of Trial Master File (TMF) content.

Study Execution & Oversight

  • Monitor study timelines, metrics, and performance using tracking and reporting tools.

  • Implement corrective and recovery actions where required.

  • Conduct accompanied field visits and oversee clinical monitoring activities.

  • Ensure alignment of deliverables with ICH GCP, regulatory expectations, and contractual commitments.

Cross-Functional Collaboration

  • Work directly with Project Managers, Data Management, Safety, Regulatory, and other functional teams.

  • Present project information during bid defenses, kick-off meetings, and client discussions.

  • Address questions from study sites on protocol, patient enrollment, documentation, and compliance.

Start-Up and Regulatory Activities

  • Manage regulatory submissions, essential document collection, and start-up processes where applicable.

  • Review ethics submissions and maintain compliance with local/global regulatory frameworks.

Resource & Team Management

  • Assign, manage, and delegate responsibilities among clinical team members.

  • Forecast and allocate resources based on study demands.

  • Mentor and develop junior staff while promoting operational excellence.


Required Experience

  • Minimum 8+ years of clinical research experience, including leadership of global clinical teams.

  • Demonstrated expertise in hematology and oncology clinical trials.

  • Extensive experience with multi-regional clinical operations and study management.

  • Strong understanding of GCP, ICH guidelines, and regulatory requirements.


Preferred Therapeutic Areas

Experience in one or more of the following indications is highly valuable:
Ovarian Cancer, Sickle Cell Disease, Non-Hodgkin’s Lymphoma, Multiple Myeloma, Glioma, Head & Neck Cancers, Pancreatic Cancer, Prostate Cancer, NSCLC, Breast Cancer, Colorectal Cancer, Radiopharmaceuticals, Cell & Gene Therapy, CAR-T Therapy.


Education Requirements

  • Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or related field.

  • Advanced degree (MS, PhD, MD, PharmD) preferred.


Skills & Competencies

  • Strong leadership ability with proven team-mentoring capability.

  • Excellent planning, prioritization, and organizational skills.

  • Strong interpersonal skills for working in a global, matrixed environment.

  • Expertise in risk management, issue escalation, and decision-making.

  • Comprehensive knowledge of clinical monitoring practices and trial conduct.

  • Proficiency with key systems: MS Office, CTMS, eTMF platforms.

  • Ability to lead independently on clinical-only studies.


Working Environment

  • Remote role requiring clear communication across global teams.

  • Must be able to work standard business hours (Mon–Fri).

  • Travel requirement: up to 20% (including air, rail, and ground travel).

  • Ability to perform effectively under tight deadlines and multiple priorities.


Join Our Mission

At Thermo Fisher Scientific, we are committed to enabling our teams to thrive while accelerating the delivery of safe and effective therapies for critical health needs. If you are driven by integrity, innovation, involvement, and intensity—and motivated to lead impactful clinical programs—this role offers an opportunity to shape the future of global healthcare.