PRAHS 2018-50899 in United States
Responsible for successfully providing data management deliverables that meet internal and external client needs.
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);
- 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.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/
Post End Date: 3/29/2019