Program Data Manager - Remote
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Program Data Manager (PDM) to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The Program Data Manager (PDM) is responsible for timely and high quality data management deliverables. PDM is the single point of contact for the cross functional and study teams. PDM is accountable for all data management activities including but not limited to create, review and monitor data collection, data review, query management, application of standards to one or multiple clinical trials; identify trends; leads data quality and is responsible for the integrity of clinical data.·
This is a sponsor-embedded position within our Functional Services Group.
Responsible for all Data Management (DM) activities including the application of data standards, data management plan, risk indicator, and third party data.
- Ensures and/or affirms study start up documentation aligns with Data Standards and Standard Operating Procedures (SOPs)
- Develops and/or ensures quality in the database design including both CRF and non-CRF data collection modules, edit checks and data review listing, and other activities up to database release
- May be responsible for risk-based monitoring setup
- Ensures final database DM documents are complete and all data issues have been tracked, reviewed, reconciled, and resolved per SOPs
- Proactively drives quality of deliverables as well as ensures timelines and milestones are met in collaboration with cross functional teams
- Escalates issues from DM teams as needed
- Works directly with the cross functional team to support day to day interactions for DM activities
- Ensures consistency and quality of the data management activities
- Trains and follows Standard Operating Procedures as applicable
- Performs other duties as assigned
- Bachelor degree, or international equivalent from an accredited institution, preferably in a technical,clinical, or health-related field, or equivalent combination of education, training and experience·
- 5-10 years of practical experience in database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave,DataLabs, etc).
- Must have at least 3 years of lead experience
- Demonstrates excellent English verbal and written communication skills·
- Excellent computer skills in a Microsoft Windows environment including proficiency in the MicrosoftOffice Suite of tools (eg - Outlook, Work, Excel, etc)·
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership ·
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities ·
- Project management experience preferred