Job Title: Senior Clinical Team Manager – Nephrology / Cardiovascular & General Medicine (CVGM)
Location: Remote, North Carolina, United States of America
Job Type: Full-time
Job Category: Clinical Research
Remote/Onsite: Fully Remote
Job Id: R-01328250
Company Overview:
PPD, part of Thermo Fisher Scientific, is a global contract research organization (CRO) delivering clinical research services that advance drug development. The Clinical Research team brings scientific and operational expertise to develop therapies for complex health challenges.
Work Schedule:
Standard (Monday–Friday)
Environmental Conditions:
Office-based with remote flexibility
May have exposure to healthcare/lab-related hazards
Independent travel up to 20% (automobiles, airplanes, trains)
Role Overview:
The Senior Clinical Team Manager (CTM) combines therapeutic knowledge, leadership skills, and project management expertise to ensure successful clinical trial execution. This role is responsible for managing clinical teams, overseeing operational and quality aspects of studies, and delivering clinical outcomes within scope, timeline, and budget.
Therapeutic Focus:
Nephrology (highly preferred): CKD, IgAN, Kidney Transplant, Lupus Nephritis
Additional therapeutic areas: Cardiovascular, Dermatology, GI (UC/CD), Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women’s Health, Rheumatology (RA, SLE, Gout), Cell & Gene Therapy, CAR-T in Autoimmune
Key Responsibilities:
Clinical Operations & Quality Management:
Manage all clinical operational and quality aspects of assigned studies (moderate to high complexity) in compliance with ICH GCP.
May assume Lead CTM or Clinical Study Manager (CSM) responsibilities on a regional level.
Develop and implement clinical tools (Monitoring Plan, Monitoring Guidelines) and contribute to the Master Action Plan (MAP).
Ensure timely set-up, organization, and quality of Trial Master File (TMF) sections (local and central).
Participate in design and review of CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents.
Team Leadership & Collaboration:
Lead clinical team members, ensuring workload prioritization, training, and guidance.
Regularly communicate with the team, lead meetings, and maintain timelines, resources, and quality.
Collaborate with other departments to achieve project deliverables.
Implement and train standardized clinical monitoring processes.
Project Delivery & Oversight:
Ensure achievement of final clinical deliverables within contractual timelines and quality standards.
Monitor clinical activity metrics, provide status updates, and implement recovery actions as needed.
Conduct Accompanied Field Visits (AFVs) and manage project financials.
Coordinate start-up activities and ensure regulatory compliance and timely submissions.
Manage clinical resource allocation, delegation, and identification of additional requirements.
Communicate with study sites regarding protocol, CRF completion, patient participation, and study-related issues.
Education & Experience:
Bachelor’s degree or equivalent formal academic/vocational qualification
8+ years of relevant clinical research experience
Previous CTM or Clinical Lead experience is preferred
Nephrology experience highly preferred (CKD, IgAN, Kidney Transplant, Lupus Nephritis)
Knowledge, Skills & Abilities:
Strong leadership, mentoring, and team integration skills
Effective planning, prioritization, and organizational abilities
Excellent interpersonal and problem-solving skills for matrixed environments
Change management understanding
Comprehensive knowledge of clinical monitoring practices and processes
Strong judgment, decision-making, risk management, and escalation skills
Effective oral and written communication in English
Ability to assess workload against project budgets and adjust resources
Financial acumen including budgeting, forecasting, and fiscal management
High attention to detail and regulatory knowledge (ICH/GCP, FDA guidelines, etc.)
Proficiency in computer systems and applications (Outlook, Excel, Word)
Capable of independently managing clinical-only studies
Working Environment:
Communicate effectively with diverse groups
Work upright and stationary for standard working hours
Ability to work under pressure, handle multiple projects, and adapt to non-traditional environments
May be exposed to healthcare or laboratory hazards
Travel up to 20% required
Company Values (4i):
Integrity
Innovation
Intensity
Involvement
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