Clinical Research Program Manager - TMF

CHDI Foundation; Princeton (NJ); Hybrid; USD 39,000 - 177,000; Full time

Job summary

An established industry player is seeking a Clinical Research Program Manager to join their dedicated team. This role involves managing clinical studies focused on Huntington’s disease, collaborating with diverse partners, and ensuring compliance with regulatory standards. The ideal candidate will possess strong project management skills and a keen eye for detail, thriving in a fast-paced environment. This is an opportunity to contribute to meaningful advancements in biomedical research while working in a hybrid setting that promotes work-life balance. If you're passionate about making a difference in clinical research, this role is for you.

Benefits

Health Insurance

Flexible Work Hours

Professional Development Opportunities

Remote Work Options

Paid Time Off

Retirement Plan

Team Building Activities

Wellness Programs

Qualifications

• Experience in clinical research project management and trial management.
• Strong attention to detail and ability to multitask in a fast-paced environment.

Responsibilities

• Manage clinical studies and vendor relationships effectively.
• Oversee TMF processes and ensure compliance with regulatory requirements.

Skills

Clinical Research Management

Project Management

Vendor Management

Regulatory Compliance

Communication Skills

Problem-Solving

Education

Bachelor’s or Master’s degree in life sciences

Project Management Certification (PMP)

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

MS Project

Job description

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Job Location

Job Title

Clinical Research Program Manager (CPM)

Job Location

The position will be based in Princeton, N.J. (currently hybrid-2 days per week in the office) with occasional travel.

Job Reports To

Director of Clinical Operations

Other

Vaccination against COVID-19 is a prerequisite for employment at CHDI Management.

Job Description

CHDI is a privately-funded, not-for-profit biomedical research organization devoted to a single disease – Huntington’s disease (HD). Our mission is to develop drugs that will slow the progression of HD and provide meaningful clinical benefit to patients. CHDI is a “science first” organization; our foremost consideration is to do the best science as quickly and efficiently as possible.

CHDI’s Clinical Team oversees a portfolio of projects aimed at understanding the natural progression of HD, developing the best biomarkers and outcome measures for use in clinical trials, finding ways to expedite and improve the execution of clinical trials, paving relevant regulatory pathways, and working with external partners to support their clinical development plans. The team engages a diverse array of partners to help manage this portfolio, including academic institutions, government agencies, contract research organizations (CROs), biotech and pharmaceutical companies.

We are seeking a highly motivated and organized individual to assist managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely in a team and with internal colleagues (scientific, legal and financial) and external collaborators (physicians, academic institutions, CROs, and biotech and pharmaceutical companies) on all aspects of CHDI’s clinical research and development efforts.

Job Responsibilities

A Clinical Research Program Manager will be expected to work closely with study teams, Directors and others within CHDI in the following areas:

Trial Master File (TMF)

• Lead the Request for Proposal (RFP) process for selecting and contracting with a Trial Master File (TMF) vendor and manage the vendor’s performance across multiple studies.
• Work cross-functionally with Clinical Operations, regulatory, CROs, and other third-party vendors to manage eTMF processes throughout the study lifecycle.
• Serve as the primary point of contact for TMF-related activities across assigned studies.
• Lead the planning, setup, and oversight of the TMF, ensuring timely filing and overall health of the TMF throughout the study.
• Collaborate with cross-functional teams and CRO vendors to ensure TMF compliance with CHDI SOPs, GCP, and applicable regulatory requirements.
• Oversee regular Quality Control activities, including conducting assessments and evaluating the completeness and accuracy of the TMF in line with the TMF plan.
• Develop and maintain TMF management plans, filing matrices, SOPs, and training materials.
• Monitor TMF completeness, timeliness, and quality; generate metrics and reports for internal and external stakeholders.
• Lead or support TMF reconciliation activities between sponsor and CRO vendors.
• Lead TMF preparation for audits and regulatory inspections; support inspection readiness efforts and participate in inspection-related activities as the TMF representative.
• Provide TMF training and guidance to internal teams and external collaborators.
• Identify and implement process improvement initiatives to increase TMF efficiency and compliance.
• Work with clinical operations and study management teams to address TMF-related CAPAs.
• Manage TMF vendor(s) and eTMF platforms.
• Oversee additional vendors and service providers, ensuring their activities align with project goals and compliance requirements.
• Develop, manage, and monitor budgets related to CHDI agreements, ensuring financial efficiency, adherence to contract terms, and alignment with overall project objectives.
• Provide regular financial reports and address any budgetary variances and drive contract amendments as needed.
• Work closely with clinical operations, finance, legal, and other departments to ensure cohesive management of vendor activities.
• Serve as the primary point of contact between vendors and internal teams, facilitating communication and resolving any cross-functional challenges.
• Develop and maintain detailed project plans for all vendor management activities, including timelines, milestones, and deliverables.
• Provide regular updates to senior leadership, highlighting key achievements, risks, and issues.
• Continuously assess and enhance vendor management processes, incorporating lessons learned and industry best practices to improve efficiency and effectiveness.
• Develop and review project descriptions, project budgets, and associated contracts (e.g., funding, CROs, etc.) to assure compliance with Foundation policies.

Clinical study management

• Manage and drive various aspects of select clinical studies and process improvement projects.
• Proactively identify issues and facilitate discussion of potential solutions that can be implemented by the project team.
• Maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, pharma/biotech companies).
• Liaise with internal and external stakeholders, such as CHDI legal and finance, other clinical team members, institutional review boards, and site staff (as needed), etc.
• Develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, SOPs, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed.
• Anticipate areas of risk, and plan and implement solutions to mitigate these risks.
• Assure good communication among the project team which is made up of members from within the organization and outside vendors/collaborators.
• Track and report on progress of clinical projects to the extended project team and management as appropriate.

Qualifications

The successful candidate will have:

• Bachelor’s or Master’s degree in life sciences, health sciences, project management, regulatory, clinical research, or related field
• Experience in pharmaceutical industry/biotech/CRO/TMF management/academic experience in clinical research project/trial management including budgeting, contracting and study execution
• Experience in managing vendors and eTMF systems, including RFP processes and contract negotiations
• Knowledge of, and experience applying TMF reference model, GCP and ICH Guidelines, including detailed knowledge of clinical document management
• Proactive, creative problem-solving skills and be open to innovative solutions
• High attention to detail and care about the quality of their work
• Demonstrated ability to multitask, prioritize responsibilities, and work effectively in a fast-paced environment
• Demonstrated ability to work independently in a distributed, interdisciplinary, team-oriented environment
• Excellent communication skills (including ability to write clearly and concisely), with the ability to work effectively with cross-functional teams and external collaborators
• Excellent project management skills, with the ability to manage multiple complex projects simultaneously
• Proficiency and willingness to expand/improve their skills in the following Microsoft applications: Excel, PowerPoint, and Word
• Be comfortable in a fast-paced, dynamic, and highly detailed-oriented environment
• Willingness to travel as needed to visit study sites and attend meetings or training sessions

Additional Skills

An ideal candidate might also have:

• Knowledge of regulatory requirements related to clinical trials and vendor management experience in managing other SaaS vendors (CTMS, ePRO, EDC, etc.)
• Experience in a global clinical research environment
• Certification in Project Management (PMP) or Clinical Research (ACRP/SoCRA) is a plus
• Advanced skills using Excel to develop tracking and budget/invoicing spreadsheets
• Proficiency in MS Project and other project management tools and software
• Experience with regulatory document management
• Experience working on CNS clinical research or drug development
• Experience negotiating vendor agreements

About CHDI Foundation, Inc.

CHDI is a private, not-for-profit research organization. We work with an international network of scientists to discover drugs that slow the progression of Huntington’s disease (HD) and provide meaningful clinical benefit to patients. We seek to accelerate scientific progress by serving as a collaborative enabler. We encourage and support cooperation and collaboration among HD researchers. Our strategy is to encourage researchers to develop practical ideas, useful research materials, and powerful technologies, often by providing financial support.

Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials.

About CHDI Management, Inc:

CHDI Management, Inc. was established in 2002 to provide administrative, management and grant making services to CHDI Foundation, Inc.

About Our Donors

CHDI’s activities focus solely on the identification and development of drugs that delay or slow Huntington’s disease. We are indebted to our donors, whose generosity and guidance have made possible this exclusive focus on science.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Information Technology

• Industries

  Internet Publishing

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