Clinical Research Program Manager

CHDI Management•Princeton, NJ

20h•Hybrid

About The Position

CHDI is 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.

Requirements

Bachelor’s or master’s degree in life sciences, healthcare, project management/business, or related field
Experience in pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution
Demonstrated experience in managing vendors and eTMF systems, including RFP processes and contract negotiations
Knowledge of, and experience applying 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
Proficiency and willingness to expand/improve their skills in the following Microsoft applications: Excel, PowerPoint, and Word
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
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

Nice To Haves

Advanced skills using Excel to develop tracking and budget/invoicing spreadsheets
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
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

Responsibilities

Lead end‑end vendor management, including selection, onboarding, contract negotiation, renewals, and termination.
Oversee CROs and service providers to ensure alignment with project objectives, quality standards, timelines, and regulatory requirements.
Develop, manage, and monitor project budgets; track invoices, address variances, and identify cost‑efficiency opportunities.
Monitor vendor performance against Service Level Agreements (SLAs) and Key Performance Indicators (KPIs); lead performance reviews and corrective action plans.
Identify and mitigate vendor‑related risks and manage scope changes and escalations in collaboration with Clinical Operations, Science, Legal, and Finance.
Serve as the primary liaison between vendors and internal teams; provide regular status, financial, and risk updates to leadership.
Continuously improve vendor management processes and strengthen strategic vendor partnerships.
Manage key aspects of assigned clinical studies and related process improvement initiatives.
Develop and/or oversee essential study documentation, including protocols, case report forms, standard operating procedures, monitoring plans, and communication tools.
Coordinate with internal teams, institutional review boards, study sites, and external partners across academia, industry, government, and non‑profits.
Proactively identify risks and issues, implement mitigation strategies, and ensure clear communication across project teams.
Track, analyze, and report study progress to project teams and management.
Support site management activities and address operational needs to ensure successful study execution.