Overview
Clinical Data ManagerNote for Applicants: This position will begin as a full-time temporary assignment scheduled for 40 hours per week. The assignment is currently anticipated to continue roughly 6 months, though timelines may change based on business needs and project demands.
Depending on business needs, funding, and individual performance, there may be future consideration for extension or conversion to a regular full-time employee position. Conversion or extension is not guaranteed.
The Clinical Data Manager (CDM) to oversee the collection, processing, and management of clinical trial data. The CDM ensures that data is accurate, complete, and verifiable according to protocol specifications, regulatory requirements (e.g., FDA, EMA), and Good Clinical Practice (GCP) guidelines.
Responsibilities
- Develop and maintain data management plans DMPs, data validation specifications, and other study related documents.
- Design and review CRFs eCRFs in collaboration with clinical teams and vendors.
- Oversee the setup, validation, and ongoing maintenance of electronic data capture EDC systems, example, Medidata Rave, Oracle InForm, Veeva, REDCap.
- Perform and review data cleaning, query generation, and issue resolution activities.
- Ensure timely and accurate database lock and data delivery to biostatistics and other stakeholders.
- Coordinate with CROs, EDC vendors, and central laboratories to ensure timely and compliant data activities.
- Liaise with internal teams clinical, regulatory, biostats, safety to ensure alignment of data deliverables with study goals.
- Participate in study team meetings and contribute to project timelines and risk management.
- Ensure compliance with regulatory requirements, example, FDA 21 CFR Part 11, ICH GCP.
- Conduct or support audits, data review meetings, and internal quality checks.
- Maintain accurate and complete documentation for inspection readiness.
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Bachelor's Degree Life Sciences, Health Information Management, Computer Science, or related field. Required
- Master's Degree Life Sciences, Health Information Management, Computer Science, or related field. Preferred
- 4-6 years -3 6 years of experience in clinical data management (pharmaceutical, CRO, or biotech experience preferred). Required
- 1-3 years Prior experience with EDC systems and CDISC standards (SDTM/ADaM) preferred. Preferred
- Proficiency in EDC systems as Medidata Rave, Veeva, InForm. High
- Familiarity with data standards as CDISC, MedDRA, WHODrug. High
- Experience with database lock processes, query management, and edit checks. High
- Knowledge of SAS, SQL, or other data handling languages is a plus. High
- Strong attention to detail and organizational skills. High
- Excellent communication and interpersonal abilities. High
- Ability to manage multiple projects and deadlines. High
- team oriented mindset with proactive problem solving skills. High
If you're looking for a career where your work
advances global health and where
scientific excellence meets real-world impact, join us and be part of something bigger.
One Team, One Purpose.CONNECT WITH US!Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
