About the RoleThe Project Manager will be responsible for planning, organizing, and managing project activities while ensuring successful execution and timely delivery.
The ideal candidate will have strong project management experience and a background working with clinical data, healthcare, life sciences, regulatory environments, or related technology programs.
Key Responsibilities- Lead the day-to-day planning, coordination, and execution of assigned projects and workstreams.
- Develop and maintain project plans, schedules, milestones, and deliverable tracking.
- Manage project resources, staffing, risks, issues, dependencies, and action items.
- Monitor project progress and provide regular status reports to internal leadership and client stakeholders.
- Coordinate cross-functional teams, including business, technical, data, and operational teams.
- Facilitate project meetings, Agile ceremonies, and stakeholder discussions.
- Maintain project documentation, including project management plans, integrated schedules, risk and issue logs, and status reports.
- Ensure project deliverables meet established quality standards and are completed on time.
- Identify potential project risks and issues and develop mitigation strategies.
- Serve as a key point of contact between clients, stakeholders, technical teams, and project leadership.
- Support effective communication and collaboration across multiple teams and organizations.
- Support transition activities and ensure continuity of project operations.
Required Qualifications- Bachelor's degree in Business, Information Technology, Healthcare, Life Sciences, or a related field.
- Strong experience managing complex technology, data, healthcare, life sciences, or regulatory-focused projects.
- Knowledge or working experience with clinical or regulatory data standards.
- Familiarity with CDISC standards, including SDTM, ADaM, SEND, and related clinical data standards.
- Understanding of data management, data quality, regulatory requirements, or data governance processes.
- Strong experience with project planning, scheduling, risk management, issue management, resource coordination, and deliverable management.
- Excellent communication, leadership, and stakeholder management skills.
- Ability to work effectively with technical and non-technical teams.
- Experience working in Agile and/or Scrum environments.
Preferred Qualifications- PMP certification.
- Certified ScrumMaster (CSM) or other Agile certification.
- Experience supporting Federal, healthcare, life sciences, pharmaceutical, or regulatory organizations.
- Experience managing data management, data quality, or data modernization initiatives.
- Experience with clinical research, clinical trials, regulatory submissions, or healthcare data.
- Experience working with Government clients and cross-functional stakeholder groups.
Additional RequirementsCandidates must be able to meet applicable client requirements, including background investigation, security clearance or Public Trust requirements, confidentiality agreements, and mandatory training.
