- 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.
PLUS – Additional Nice-to-Haves
- 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.
For candidates within 50 miles of a Facility: Up to 2 days work from home permitted immediately upon hire. An additional work from home day (up to a total of 3 days) permitted following a 3 month probation period. The third work from home day may be permitted based upon performance, managers approval and EDEV Head concurrence.
For candidates more than 50 miles of a facility with a documented remote arrangement: Full time remote will apply if previous, documented regional employment exists.