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);

  • 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.

ID: 2018-50899

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/

Post End Date: 3/29/2019