Description
We are looking for a Medical Data Review Manager to join our team!
This is a home-based, global scope position.
Job Overview Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.
Essential Functions
- Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy.
- Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial.
- Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages.
- Review all reported Adverse Events (AEs), Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.).
- Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial.
- Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient.
- Review any other information as necessary to determine overall readiness of the patient information for next level review.
- Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items.
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
Qualifications
- Bachelor's Degree in Medicine, graduated and specialized in Rheumatology (mandatory - we can only consider physicians for this role).
- 5 years of related experience in clinical research - research site level or CRO/Pharmaceutical companies. Experience as Sub-Investigator or Principal Investigator are relevant.
- Advanced English level - great communication skills in the language. The role has a global scope.
- Understanding of clinical/medical data related to clinical trials.
- Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.
- Excellent motivational, influencing and coaching skills.
- Ability to work on multiple projects and manage competing priorities.
- Strong customer focus skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.