POSITION SUMMARY:The Program Manager of Clinical Study Operations provides cross-functional program management support for Organ Health and Women's Health clinical studies during a temporary maternity leave coverage period. This role is responsible for coordinating activities between Scientific Operations, Clinical Study teams, Research, Laboratory Operations, and other cross-functional stakeholders to ensure clinical studies are executed efficiently and according to timelines. The individual will drive communication, track deliverables, manage risks and dependencies, and support operational execution across multiple concurrent studies in a fast-paced environment.
PRIMARY RESPONSIBILITIES:- Provide day-to-day cross-functional program management within Scientific Operations to support Organ Health and Women's Health clinical studies.
- Coordinate activities and communication between Scientific Operations, Clinical Operations, Research, Laboratory Operations, Data Management, and external partners as needed.
- Lead recurring cross-functional meetings, document key decisions, track follow-up actions, and escalate risks or delays appropriately.
- Monitor study operational milestones, sample logistics, deliverables, and dependencies to ensure studies remain on track.
- Prepare project status updates, and presentations for functional leadership and stakeholders.
- Support process improvement initiatives and operational workflows related to clinical study execution.
- Assist with study documentation, SOP coordination, protocol operationalization, and other operational deliverables as needed.
QUALIFICATIONS:- Bachelor's degree in Life Sciences, Clinical Research, or related field required.
- 3+ years of program or project management experience in biotechnology, diagnostics, pharmaceutical, or clinical research environments.
- Demonstrated experience supporting clinical trials or clinical studies across cross-functional teams.
- Experience coordinating work between clinical, laboratory, and research organizations preferred.
- Strong understanding of clinical study operations, timelines, risks, and stakeholder management.
- Program or project management certification or formal training is a plus.
- Experience using project management and collaboration tools such as Smartsheet, Jira, Confluence is preferred. Experience with sample repository databases such as Labkey is a plus.
KNOWLEDGE, SKILLS, AND ABILITIES:- Excellent communication and interpersonal skills with the ability to collaborate effectively across scientific, clinical, operational, and leadership teams.
- Strong organizational skills and attention to detail in a fast-paced and evolving environment.
- Ability to proactively identify risks, drive issue resolution, and maintain accountability across teams.
- Experience facilitating cross-functional meetings and presenting status updates to leadership.
- Proficiency with Google Workspace, Microsoft Office Suite, and project tracking tools.
- Duties are typically performed in an office or hybrid office environment.
- This position requires the ability to use a computer keyboard, communicate over video conferencing platforms and telephone, and read printed material.
- Duties may require working outside normal business hours at times to support project timelines and cross-functional coordination.
- The role may involve extended periods of sitting and computer-based work.
