Clinical Trial Project Manager

The Clinical Trial Project Manager – Network Support is responsible for executing and supporting clinical trial activities across the full study lifecycle, from study start-up through maintenance and close-out, across multiple sites within the DM Clinical Research network.

This role functions as an execution-focused individual contributor supporting centralized network oversight. The Project Manager may be assigned to focus on specific lifecycle phases (e.g., study start-up, study maintenance, amendments, close-out) based on operational priorities, while maintaining familiarity with end-to-end trial workflows.

DUTIES & RESPONSIBILITIES

1. General Trial Lifecycle Support

a. Support assigned clinical trials across one or more lifecycle phases, including study start-up, active study maintenance, amendments, and study close-out.

b. Maintain accurate study-level trackers, timelines, and task lists to ensure visibility into study progress and deliverables.

c. Monitor assigned milestones and proactively flag risks, delays, or gaps to centralized oversight for guidance and resolution.

d. Coordinate with internal teams (Regulatory, Site Operations, Clinical Data, Contracts & Budgets, Patient Engagement, etc.) to support timely and compliant trial execution.

e. Support documentation completeness, accuracy, and readiness in accordance with study requirements and organizational SOPs.

2. Study Start-Up (as assigned)

a. Track regulatory and contractual deliverables required for site activation.

b. Support IRB submissions, responses, and activation readiness activities.

c. Assist with amendment-related start-up activities as needed.

3. Study Maintenance (as assigned)

a. Support ongoing study activities post-activation, including:

i. Tracking visit readiness and milestone completion

ii. Monitoring protocol amendment implementation

iii. Supporting issue resolution tracking and follow-up

b. Assist with maintenance of essential documents and study-level compliance tracking

4. Study Close-Out (as assigned)

a. Support close-out activities, including documentation tracking, reconciliation support, and final deliverable coordination.

b. Assist with readiness tracking for study close-out milestones.

5. Reporting & Communication

a. Prepare routine internal status updates and reports to support centralized oversight and decisionmaking.

b. Participate in internal meetings related to assigned trials as required.

c. Escalate risks and issues through established internal pathways.

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor’s degree preferred.

Experience:

• 4–6 years of experience in clinical research or clinical trial operations
• Experience supporting multiple phases of the clinical trial lifecycle
• Experience working within a site network, SMO, CRO, or sponsor environment

Credentials:

• Certification in Project Management, such as ACRP-PM, or a related qualification in the field.

Knowledge and Skills:

• Working knowledge of U.S. clinical trial regulatory processes and GCP requirements
• Strong execution and organizational skills
• Ability to manage multiple studies and priorities in parallel
• Clear written and verbal communication skills
• Detail-oriented with strong follow-through
• Comfortable working in a fast-paced, changing operational environment
• Proficient with standard productivity tools (e.g., Microsoft Office, Google Workspace)