Over 470 pra biometrics resources currently in fte programs across 12 global clients Resources located in north america, south america, china and europe Roles include embedded, dedicated leadership structure + all levels of data managers, stats programmers, biostatistics, ivrs, epro, medical coding Several teams are remote, others partially based in pra philadelphia headquarters, others at sponsor sites, global pra facilities Management almost always grown from within, with a pra manager in place for every team Teams range in size from 1 resource to 200+ and several relationships have been established for 5, 10, and 15+ years!
Our motto: one client! one team! one set of processes to learn! Why join ssd biometrics?
Pto policy is very competitive Employee stock purchase plan Have you had a chance to see our sweet office in blue bell? Significant return rate of pra ex-employees Get involved in client initiatives, process improvements, investigator meetings, training, mentoring…..break out of the day-to-day See the results of your work through direct discussions, meetings, townhalls and teambuilding events with client leadership Upward mobility for those that are interested – our ssd leadership structure is primarily built from within and have been in place with us for 5, 10+ years! High retention of team members and management means stable teams and positive program culture Permanent pra employees with examples of opportunities to convert to client perm roles Significant global industry conference participation, scdm, jsm, phuse, pharmasug, dia.
Electronic data capture (edc) experience:
At least two (2) years of experience with a major edc tool (inform, rave, oracle clinical, or similar) Study startup/build activities, including working with a standards library User acceptance testing (uat) Data review and cleaning (running of queries and reports) Data reconciliation Database lock
Extensive experience managing study start-up, conduct, and lock in the data management space:
Knowledge of, and familiarity with a standards library, and the mapping of protocols to data standards Success in conducting/leading meetings, including user review (olsr – online screen review) meetings Involvement with cross-functional teams, including programming and biostatistics Experience with external data vendors: understanding specifications to import multiple types of data, working with technical groups to ensure timely loads of external data sets into the sponsor's database. Knowledge of epro/ecoa instruments, and their use in clinical studies.
Documented experience in translating clinical protocols into electronic case report forms and developing the associated data validation specifications (e.g., edit checks, reports). Proven ability to run multiple concurrent studies while also participating in special projects or process improvement initiatives. Ability to represent the department on cross-functional study teams and cross-functional project teams. Demonstrated experience in providing customer-focused support, with satisfactory examples provided. Excellent written and verbal communication skills. Strong presentation skills, including the ability to represent yourself and the department in front of customers and stakeholders. Ability to work within short and compressed study timelines. Ability to multi-task, work independently, and act with appropriate accountability. Understanding logistics in the laboratory space (e.g., pk/pd analysis, sample management, etc.)
4+ years of clinical data management experience. 1+ year(s) of experience as a lead data manager within phase i, including having completed at least one (1) study start/setup and one (1) database lock. College degree is desirable, but not required if supplemented by sufficient work experience.
Pra is an eeo/aa employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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Lead Data Manager
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