Full-Time Senior Clinical Project Manager

The Senior Clinical Project Manager/Clinical Project Manager is a team-player role supporting clinical operations for our programs.

This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across disciplines to drive a key program through all phases of clinical trials (Phase I-III).

The role is within the Clinical Development organization and involves working closely with vendors and clinical sites.

As a Senior Clinical Project Manager/Clinical Project Manager at Glycomine, you'll play a pivotal role driving critical clinical programs.

You'll provide support and experience to the program and members of our Clinical Development team to ensure seamless clinical trial execution.

You'll collaborate across functions, support key initiatives, and ensure timely, on-budget trial completion adhering to the highest quality standards.

Responsibilities include, but are not limited to:

• Preparing/reviewing site feasibility reports and supporting study team in site selection.
• Ensuring efficient study start-up, overseeing CROs and vendors and working with relevant team members.
• Ensuring timely collection of start-up documents (ethics, agreements, etc.) prior to site activation.
• Working with the Director of Clinical Operations to review study timelines and milestones.
• Managing scope of work, change notifications, contract modifications, site trial agreements, and budgetary information.
• Reviewing site visits, conducting study oversights as needed.
• Overseeing vendor activities (CROs, labs, etc.).
• Assisting in study plan preparation and implementation (Monitoring Plan, Oversight Plan, etc.).
• Collaborating with internal teams (Clinical Development, Regulatory Affairs, Translational Medicine) to ensure alignment.
• Serving as point of contact for CROs and vendors, overseeing performance and adherence to agreements, timelines, and quality.
• Ensuring compliance with regulatory requirements (ICH-GCP, company SOPs).
• Overseeing clinical trial data collection, analysis, and interpretation.
• Contributing to the preparation and review of clinical study documents (Investigator Brochure, INDs, protocols, reports, etc.).
• Forging relationships with investigators, site staff, and CROs.
• Contributing to operational risk management strategies.
• Overseeing clinical and regulatory files, including TMF.
• Supporting timely exchange of information for clinical trial deliverables.
• Managing clinical trials from start-up to close-out ensuring internal and external deliverables are on time and on budget.
• Proactively managing outsourced partners, identifying risk to ensure trial deliverables and performance goals.
• Maintaining partnerships with CRO counterparts; proactively reviewing sites and communicating/escalating issues.
• Collaborating with CROs to maintain a current, accurate, and routinely cleaned clinical study database.
• Supporting and managing oversight activities of vendors to ensure operational excellence.

Ideal candidate:

• BA/BS (health-related field preferred) or MA/MS (biological/life science/nursing preferred, but not required)
• 5+ years clinical operations experience in pharma/biotech
• Strong CRO management and relationship-building experience
• Strong clinical trial management skills
• Demonstrated success in program and trial execution
• Drug development domain expertise (early-stage clinical trials preferred)
• Strong vendor and project management skills
• Ability to manage multiple priorities and adapt to changes
• Strong communication, interpersonal, and problem-solving skills
• Comfortable in a fast-paced environment
• Global studies (multiple countries/sites) experience required
• Pediatric trials/rare disease experience preferred
• Strong working knowledge of GCP/ICH and applicable regulations/guidelines
• Strong written and verbal English
• Domestic/international travel may be required

Note: All information is confidential according to EEO guidelines. Remote, East Coast time zone preferred. Full-time position. Possible employment type: Full-time.

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