Job Description
Responsibilities
Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
Perform quality control and audit activities to ensure data accuracy and compliance.
Support data reviews and provide metrics and status updates to project teams and leadership.
Requirements:
Bachelor's degree in Life Sciences, Computer Science, or a related field.
Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.
Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
Strong knowledge of CDISC standards, including SDTM and ADaM.
Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
Exceptional attention to detail and problem-solving skills.
Ability to work independently and communicate effectively with diverse stakeholders.
Job Tags
Similar Jobs
Christus Health
DescriptionPOSITION SUMMARY: Participates in general accounting and financial reporting services of the Region and its affiliates. Month... ...reportingRequirementsMINIMUM QUALIFICATIONS:EDUCATION: Bachelor's degree in Accounting or four years of experience in accounting...
Bitrix Infotech Pvt. Ltd.
# Design visually appealing and user-friendly website layouts and interfaces # Convert design mockups into responsive HTML/CSS templates... ...new design elements and features # Follow best practices in web design, accessibility, and SEO # Stay updated with current...
Sway
...questions, then we want YOU! We'reSway, an established event marketing and promotions company located in Jersey City, New Jersey,... ...looking to expand our dynamic team. As an Event Marketing Consultant, you'll be responsible for promoting our clients' products and...
Delicato Family Wines
...employees and visitors. Shift Information: This position is a part time role Tuesday and Wednesday 12:00am-8:30am for a total of 1... ...a generous and comprehensive benefits package. The core health insurance components include medical, dental and vision, where...
Ginas Tech Jobs
...BMC Remedy / Helix Service Desk Professional Work From Home We are looking for a qualified candidate to work as a full-time BMC Remedy... ...certification is required. Benefits include medical insurance, dental, vision, flexible spending account, retirement plan, PTO, 401K...