Description:
A prominent global pharmaceutical company is looking for a Digital Clinical Program Manager to join their Medical Digital Systems Team on a 6 month contract in Cambridge, MA. You will be working in a high-growth organization that is revolutionizing the biotech industry.
In this role, you will be leading the digital products in support of the company's clinical development organization digital program. You will work directly with stakeholders from clin. ops, patient recruitment/retention, data management, QA/QC, and digital.
You will also collaborate across the company's network of services and tech. providers to ensure definition, delivery, and operations of clinical digital solutions. Daily, you will work with clin. ops. to aid in the rollout of the solution covering a broad range of areas such as site engagement, trial management systems, and decentralized clinical trials platforms.
Responsibilities
- Define and lead digital clinical projects
- Coordinate Business Analysis
- Create and monitor project timelines
- Ensure project goals and means meet business objectives and deliver value in a timely fashion
- Collaborate across the organization to gain alignment on project objectives and deliverables
- Engage with Computer Systems Validation Lead to support validation efforts
- Create and communicate project status updates and reports
Qualifications:
- 8+ years in digital project management in a GxP environment
- Bachelor's in Computer Science, Biotechnology or equivalent required.
- Master's preferred
- Proven experience with rollout of clinical trial management systems (CTMS)
- Working knowledge of current decentralized clinical trials (DCT) platforms (g.medable, Thread, Medidata) and have supported clinical teams in deploying various aspects of DCT platforms such as eConsent, televisit and eCOA
- Demonstrable experience in systems and data integration for clinical applications (EDC, eTMF, IRT, DCT)
- Deep understanding of core clinical business processes
- Track record of using Agile approaches in a regulated environment
- Fluency in the digital world and your craft
- Direct knowledge of SaaS technology in a GxP environment
- Practical understanding of data integrity requirements
