Who we are:
* Over 470 PRA Biometrics resources currently in FTE Programs across 12 global clients
* Have grown over 40 FTEs in 2018 and continuing to expand
* 88% global team retention in 2018 (well above industry standard)
* 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. We had 32 abstracts submitted for SCDM this year, 10 attendees and 6 presenters in Seattle!
* At least five (5) years clinical data management experience.
* Experience as a Lead Data manager
* At least one (1) full year as a Lead Data Manager, including at least 1 study start/setup, and also at least 1 database lock.
* Electronic data capture (EDC) experience is mandatory.
* A minimum of two (2) years experience with a major EDC tool such as InForm, RAVE, Oracle Clinical, or similar.
* Experience should include:
* Study startup/build activities, including working with a standards library;
* User Acceptance Testing (UAT);
* Data Review and Cleaning (run queries, run reports);
* Data Reconciliation.
* Extensive experience managing study start-up, conduct and lock in the data management space:
* Knowledge of and familiarity with a Standards Library, and mapping of protocols to data standards;
* Success in conducting/leading meetings, include User Review (OLSR - OnLine Screen Review) meetings;
* Involvement with cross-functional teams including Programming and Biostatistics;
* Success in managing external vendors providing additional study data such as labs, PK, etc.;
* 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. Should also have the 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:
* At a minimum, PRA should review candidate's resume for written skills. No spelling or grammatical errors, clearly expressed thoughts and examples, etc.
* PRA to screen for verbal skills during interview. Includes but not limited to clearly spoken, grammatically correct English . English does not have to be their first language but the candidate should have sufficient skills to be able to lead meetings with confidence.
* Candidate should also have solid presentation skills. This includes a proven ability to represent both him/herself and also the department in front of customers and stakeholders.
* Stress resistant / ability to work within short and compressed study timelines.
* Candidate should be informed of the EDEV environment, specifically with regards to studies that could go from Start-up to DBL in a few months, and the associated need to deliver high-quality databases in these compressed timelines.
* PRA to determine if the candidate has prior experience working in such an environment (early phase). If not, PRA should assess the candiate's potential for success in these situations.
* An ideal candidate will have prior early phase experience, include a successful study start and a successful DBL.
* Ability to multi-task, work independently, and act with appropriate accountability
* Candidate should be informed of the standard workload expectations of an EDEV Lead, such as the ability to run concurrent studies in different phases (once the candidate is on-board and suitably trained and mentored if appropriate).
* Candidate should be informed of the expectation of being able to participate in special initiatives in addition to study work.
* Candidate should be able to demonstrate full self-accountability to lead studies according to Merck processes, interact with customers and stakeholders, complete assigned training & trackers with minimal supervision.
* Phase 1 experience
* Experience with InForm
* 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 database.
* Understanding logistics in the laboratory space (e.g. PK/PD analysis, sample management...)
* Ability to reasonably explain any gaps in the timeline of their resume.
* 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.
Associated topics: data administrator, data analyst, data analytic, data center, database, etl, erp, mongo database, sybase, teradata