Lead Data Manager - Southampton
over 2 years ago
On behalf of a Global Leader we are currently looking for a Lead Data Manager to join the partner on an initial 3 Months Contract remotely.
- The Lead Clinical Data Manager is responsible for the oversight of all Data Management tasks (including the data management technology set-up of the project) from study start-up to database lock to produce a clean and analysable database.
- Provides overall leadership and expertise in all aspect of Data Management via liaising across the external Vendors/Contractors who independently lead and/or efficiently perform all Data Management activities within an assigned study.
- The individual must be able to manage and/or execute multiple projects simultaneously and have a passion for science and evolving data analytics capabilities. The incumbent will actively partner across functional areas and geographies within the partner and with external vendors to ensure R&D project deliverables and timelines are met. Additionally, the applicant will be responsible for data standards development and SDTM review processes, including the management of external vendors who may provide these services.
- Design - Design and deliver eCRF specifications according to protocol and approved standards; oversee development of new standards.
- Manage - Manage and monitor data management activities with vendors. Assist in development of request for proposal (RFP) for data management needs and manage external contractors as applicable.
- Lead - Oversee vendors (as required) as point of contact between vendor and the partner for all data management activities. Provide support for DM Vendors to include: all data management activities with vendor (data management plan, eCRF screens, database configuration specifications, data validation specifications, protocol deviation specifications, SAE & vendor data reconciliation, User Acceptance Testing (UAT), coding, database lock, etc.,) to make sure internal study team is updated on these activities. Provide thought leadership on DM strategies, including EDC platforms and outsourcing.
- Collaborate - Proactively collaborate with appropriate project teams to lead and shape changes that enhance data collection, cleaning, data transfers and data analysis. Participate in regular team meetings (both internal and external) and provide updates as needed.
- Communicate - Effectively communicate to and manage internal project teams, CROs and other third-party vendors. Hold team meetings on a regular basis.
- Manage - Effectively manage in-house and outsourced project delivery. Highlight issues/risks to delivery and mitigate risks for both partner and the CROs, developing contingency plans for the project. Accountable for quality control of project deliverables and timely delivery of projects. Actively partner across functional areas within the partner and with external vendors to ensure R&D project deliverables and timelines are met.
- Additionally, the candidate will be responsible for the oversight of global DM processes such as data standards development and SDTM review processes, including the management of external vendors who may provide these services.
EXPERIENCE, SKILLS, KNOWLEDGE
- Demonstrable experience in clinical/data management facilitating data management and data science activities with clinical and/or non-clinical experience. Good working knowledge of ICH and FDA relevant guidelines for data management activities.
- Excellent working knowledge on CDISC standards with emphasis on CDASH, STDM and ADaM.
- Deep understanding of data life cycle for data from product development to registration of regulated products.
- Prepares/review relevant SOPs and training/control documents to ensure that best data management practices are maintained.
Technical / Functional / Leadership Skills Required
- Knowledge around SAS programming to organise and query datasets using BASE/SAS, including PROC SQL and SAS MACROS.
- Proficiency using multiple Electronic Data Capture Systems, such as: Oracle Clinical, Medrio, Inform, Medidata Rave, etc.
- Proactive; self-driven with strong interpersonal, organizational, and multi-tasking skills.
- Seizes opportunities to improve the Data compilation and management through its life cycle.
- Provides training and mentors other team members and wider R&D scientific community in best data management practices and data standards.
- Good communication/interpersonal skills.
Education / Qualifications / Certifications Required
- Bachelor’s Degree Required
- Previous working experience of vendor management is essential
- Experience with FDA regulatory submissions
- Implementation of CDISC, CDASH and SDTM standards
- Data Sciences knowledge