The Clinical Project Manager (CPM) coordinates clinical trial programs to achieve company goals and objectives within budget, on schedule, and in compliance with FDA, ICH, WHO and other applicable regulations. Although the CPM may provide clinical project management across one or more disease indications, this position may focus primarily on oncology clinical trials.
- Provides input into the conception, design, development, and drafting, of clinical development plans, regulatory submissions, study protocols, investigator brochures, clinical study reports, SOPs, study operations manuals, and various other clinical, regulatory and safety documents in support of clinical research projects.
- Assists in developing, monitoring and managing study budgets, and re-forecasting as appropriate.
- Develops, monitors and manages study timelines and schedules as they relate to study recruitment and other essential study goals.
- Provides guidance and oversight of daily clinical trial activities to ensure successful management of these activities within designated program budgets, timelines and quality standards.
- Participates in the evaluation and selection of consultants, CRO’s, and clinical study sites.
- May assist in negotiating contracts with CRO’s, investigational sites and laboratories for content and pricing; will also assist with invoice review ensuring that all contractual and budget elements are met.
- Assists in the management of clinical and other, related, vendors (i.e., CROs, central clinical labs, etc).
- Participates in the management of contractors and others responsible for the clinical supply chain to ensure adequate supply of study drug and other supplied components for use by clinical sites.
- May interact with principle investigators and clinical study coordinators to ensure compliance with protocols, SOP’s, overall clinical objectives, timelines, and applicable regulations.
- Assists with issue identification, management and resolution/escalation regarding quality, compliance or performance issues related to either internal or external parties participating in the Company’s clinical studies; communicates in a timely fashion program risks and issues to senior management.
- Works with the CRO(s) and study sites to develop and implement corrective and preventative actions to address variances and deviations.
- Assures the integrity of clinical data with respect to accuracy, accountability, and documentation through review of clinical lab listings, case report forms and other study records, data listings and other source documents.
- Travels as necessary to CRO’s and study sites to coordinate the Company’s clinical projects and to audit source clinical files; anticipated travel is 20% or less.
- Assists with the development and implementation of processes, systems and performance measurement mechanisms in support of clinical vendor management.
- This individual may also participate in other project activities as may be requested in support of the business.
- Bachelor’s or Master’s degree in a scientific discipline, preferably in the natural sciences (e.g. biology, chemistry) or health sciences (e.g. nursing, pharmacy).
- Minimum of five (5) years of clinical project management or clinical operations management as a clinical project manager (or equivalent scope and title), or ten (10) years as a clinical research associate (CRA), in a pharmaceutical, biotechnology or contract research organization (CRO), specifically coordinating investigational drug clinical trial projects, is required.
- A minimum of 3 years of relevant oncology clinical trials project management experience is required.
- Certification credentials in Clinical Project Management (e.g. CCPM) is highly preferred.
- Thorough and practical working knowledge of GCP/ICH and FDA regulations and guidelines.
- Adept at working in a changing environment and ability to manage multiple projects across several departments, CRO’s and clinical trial sites while influencing project decisions in coordination with clinical, regulatory and CMC timelines.
- Proficiency with Microsoft Office Suite.
- Excellent writing, presentation, communication and organization skills.
- Good interpersonal and teamwork skills.
- Ability to think creatively about both tactical and strategic issues.
- Ability and desire to work in a fast-paced, team-oriented environment.
Please submit a cover letter and resume with the subject line “Clinical Project Manager (Oncology)”
Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.
No telephone inquiries or recruiters, please.
Vaccinex, Inc. is an equal opportunity employer.