Position Overview
We are seeking a Clinical Date Project Manager to help drive the maturation of clinical data management processes and ensure alignment with industry standards and best practices. This critical role reports to the Senior Director of Clinical Development/QA IT Solutions. The ideal candidate will be responsible for delivering key capabilities supporting Development and QA organizations and will be instrumental in shaping the digital foundation.
This role requires one-day onsite in Cambridge, MA preferably on Thursday.
Key Responsibilities:
· Oversee clinical data management and the use of technology.
· Assess current technology and consider moving to cloud solutions.
· Address compliance and quality requirements.
· Engage with both clinical and technical teams.
· Provide input on training and procedural improvements while performing PM duties.
· Focus on maturing current processes for managing clinical data technologically and procedurally.
· Facilitate procedural changes and potentially alter software use for data management.
· Experience with clinical trials and data management, comfortable asking questions and providing insights.
· Drive design thinking workshops focusing on discovering key business challenges for business objectives.
· Successfully execute and deliver strategic enabling projects by building engagements with internal SMEs across IT (Cloud/Data/Infrastructure/IT Compliance) and business functions.
· Author, develop, and maintain key project documents.
· Develop high-performing project teams.
· Work with IT governance and program management for governance, standards, and practices, contributing to continual improvements.
Qualifications:
· Mid-level Project Manager with 15+ years of experience.
· Someone with an engaging personality and an excellent grasp of Pharma, especially clinical development and relevant enabling capabilities.
· Proven track record of driving successful SDLC projects.
· GxP experience preferred.
· Deep skill in structuring information.
· Open to experimenting and adapting to new ways of thinking.
Nice to Have Skills:
· Experience with Veeva or any CTMS.
· Familiarity with AWS or other cloud technologies.
· Background in clinical manufacturing.
· Experience supporting medical affairs and medical quality.
Job Type: Contract
Pay: $135,000.00 - $155,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Experience level:
Schedule:
Ability to Commute:
- Cambridge, MA 02138 (Required)
Work Location: Hybrid remote in Cambridge, MA 02138