Clinical Data Manager jobs in Lowell, MA
Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Clinical Data Manager jobs
- Ocular Therapeutix
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Bedford, MA
FULL_TIME
-
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Our robust product pipeline positions Ocular Therapeutix to become a leader in the ophthalmic space due to our ability to create drug delivery solutions that reduce the complexity and burden of the current standard of care by developing sustained release alternatives.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.Position Summary:
The Clinical Data Manager is responsible to effectively execute the data management activities and assist in oversight of data management vendors.
Principal Duties and Responsibilities include the following:
- Perform Lead DM (Data Management) responsibilities for assigned studies.
- Assist with the design of the clinical database based on protocol and study needs, including queries and dynamics
- Perform User Acceptance Testing of the clinical database
- Author study specific DM documentation (DMPs, CCGs, DTAs, EDC specifications)
- May assist in data cleaning activities for assigned studies
- Monitor study progress to ensure successful achievement of study milestones
- Provide oversight of data management vendors for assigned studies.
- Ensure that all data management operations are conducted to Ocular Therapeutix SOPs or CRO (Contract Research Organization) SOPs if applicable.
- Identify and communicate potential risks/challenges to AD of Data Management and study CPM based on protocol, timelines, forecasts, and study metrics. Assist the study team in the implementation of solutions.
- Ensure data management study documents are filed in the TMF (Trial Master File) in a timely manner.
- Oversee tasks delegated to Associate Data Managers for the assigned studies.
- Perform other duties as required
Qualification Requirements:
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
- Five years of clinical data management experience.
- Minimum 3 years of Lead DM experience at a CRO is required
- Knowledge of SOPs, GCP (Good Clinical Practice) standards, and clinical data management systems
- Must have experience with EDC systems; Zelta/IBM Clinical and Medrio experience preferred
- Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc., with expert skill in Excel required
- Excellent written and oral communication skills
- Excellent organizational skills and attention to detail
- Ability to prioritize and multitask is required
Working Conditions:
This position will be fully remote. The ability to travel less than 5% would be desirable, but not required.
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. - 2 Days Ago
- Lowell Community Health Center
-
Lowell, MA
FULL_TIME
- Company DescriptionBased in the heart of downtown Lowell, Lowell Community Health Center is currently hiring for a Health Data Analyst within in Clinical Informatics DepartmentWith nearly 400 employee...
- 1 Month Ago
- Astrion
-
Bedford, MA
OTHER
- Overview Journeyman Data Manager Be the Difference Astrion offers comprehensive services that boost preparedness, optimize performance, and ensure success across various domains, from Cyber to Digital...
- 1 Month Ago
- Caring Hearts Homecare
-
Wilmington, MA
FULL_TIME
- Job Description:Caring Hearts Homecare is looking to hire a full time Clinical Manager, someone who is self-driven, responsible, dedicated professional, to lead our Clinical department. Qualifications...
- 3 Days Ago
- Applied Research Solutions
-
Bedford, MA
FULL_TIME
- Applied Research Solutions is seeking a Configuration Data Manager (Level III) to provide configuration support and management in accordance with the program’s Configuration Management Plan, Air Force...
- 11 Days Ago
- ARS - Applied Research Solutions
-
Bedford, MA
FULL_TIME
- DescriptionApplied Research Solutions is seeking a Configuration Data Manager (Level III) to provide configuration support and management in accordance with the program's Configuration Management Plan...
- 5 Days Ago
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