Clinical Trials Project Manager Ii - Remote

2-4 years

$72,000 to $90,000 per year

Remote, USA

10 Aug. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Position Title: Clinical Trials Project Manager II

Location: Remote

Company: CPC Clinical Research

Apply Directly: CPC Careers (Internal title: Clinical Operations Manager II)

Position Overview:

Are you a highly organized individual who can adapt to unexpected changes while keeping a keen eye on both the big picture and daily tasks? If so, we have an exciting opportunity for you! CPC Clinical Research is seeking a Clinical Trials Project Manager II to serve as the primary contact for industry-sponsored clinical trials and Endpoint and Specialty Services activities.

Key Responsibilities:

Clinical Operations Management: Oversee all aspects of clinical operations, from project initiation to close-out, including managing trial-related activities and vendor payments.
Documentation & Compliance: Lead the design, writing, and review of essential project documents, including protocols, case report forms, and study reports. Ensure compliance with local, federal, and international regulations, guidelines, and CPC Policies.
Project Coordination: Define and monitor project scope, timelines, and deliverables. Identify and coordinate project-specific training for team members and manage multidisciplinary project teams.
Communication & Reporting: Provide expert advice on project-related documents and deliverables. Track and report project updates to sponsors and oversee investigator meetings.
Endpoint & Specialty Services: Manage contracted deliverables for external committees and oversee the SAE process, data entry, and cleaning of study databases. Provide operational support for biostatistics and programming deliverables.

Qualifications:

Education: Nursing degree or BA/BS in a scientific field (or equivalent experience).
Experience: Minimum of 4 years in a clinical research setting, including at least 2 years in project/operations management.
Knowledge & Skills:
- Thorough understanding of Good Clinical Practice guidelines and FDA/ICH regulations.
- Proficiency in Microsoft Office (Outlook, Word, Excel).
- Strong communication, organizational skills, and attention to detail.
- Experience managing multi-disciplinary teams and handling project-related conflicts.
- Willingness to travel 20-25%.

Compensation:

Targeted Salary: $72,000 – $90,000 annually.

About CPC Clinical Research:

CPC is a leading academic research organization with over 30 years of experience in clinical trial design, oversight, and management. We specialize in various therapeutic areas, including cardiovascular, wound healing, and diabetes. Our expertise spans industry-funded, NIH, and investigator-initiated trials. CPC Community Health focuses on innovative programs that promote active, empowered, and healthy living.

Benefits:

Comprehensive benefits package (medical, dental, vision, life, STD, LTD, etc.).
Matching 401(k) plan (dollar for dollar up to 4% of eligible compensation, fully vested immediately).
11 paid holidays and 15-25 vacation days based on years of service.
Paid sick time (2.67 hours accrued bi-weekly, up to a maximum of 80 hours).
In-suite exercise and relaxation room.
Monthly team-building events and flexible remote work options for certain positions.

To Learn More:

Visit our website to explore our values and learn more about our organization: CPC Clinical Research

Equal Opportunity Employer:

CPC Clinical Research is an Equal Opportunity Employer and provides employment opportunities without regard to race, sex, color, ancestry, sexual orientation, gender identity, marital status, religion, national origin, disability, military status, genetic information, age, or any other status protected by law. If you require assistance due to a disability, please contact our Human Resources team at careers@cpcmed.org.

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Clinical Trials Project Manager Ii - Remote

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