Clinical Data Manager II

Precision Medicine Group

2d•$100,700 - $166,100

About The Position

The Clinical Data Manager II manages the clinical trial data management process for assigned projects, from study start-up through post-database lock, under some supervision. The role follows applicable SOPs and work instructions, regulatory directives, and study-specific plans and guidelines. It also oversees and/or performs clinical database development and testing. As a lead data management contact or contributor, the Clinical Data Manager II coordinates data management activities, supports continuity and timely delivery, and may serve as a backup or team member for other projects. The role develops and maintains study documentation, oversees database quality, reviews clinical data, coordinates reconciliation and medical coding, and works with sponsors, vendors, and project teams. It may also support programming, procedural development, proposals, training, and business development activities. Occasional travel may be required.

Requirements

Bachelor’s degree and/or a combination of related experience.
At least 5 years of Clinical Data Management experience, or demonstrated aptitude in the key skills for the role.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to handle a variety of clinical research tasks.
Excellent organizational and communication skills.
Ability to read, write, speak fluently, and comprehend English to communicate across Precision for Medicine and with clients.
Experience using a clinical database management system.
Broad knowledge of drug, device, and/or biologic development and effective data management practices.
Ability to undertake occasional travel.

Nice To Haves

Understanding of dictionary medical coding, including MedDRA and WHODrug.
Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
Oncology therapeutic experience.

Responsibilities

Serve as the primary data management contact and/or contributor for assigned clinical projects or programs, ensuring backup, continuity, responsiveness, and timely task completion.
Support another Lead Data Manager as a backup and/or team member when needed.
Perform data entry for paper-CRF studies and quality control of data entry, as needed.
Provide input into timelines, ensure clinical data management deadlines are met with quality, and assess resource needs for assigned projects as needed.
Develop CRF specifications from clinical study protocols and coordinate review and feedback from stakeholders.
Assist with building clinical databases.
Conduct database build user acceptance testing, maintain quality-controlled database build documentation, and oversee overall clinical database quality.
Specify requirements for electronic, manual data review, and other edit checks.
Create, revise, version, and maintain data management documentation, and oversee its completeness in the Trial Master File.
Train clinical research personnel on study-specific CRFs, EDC, and other project-related items.
Review and query clinical trial data according to the Data Management Plan.
Perform line-listing data review based on guidance from the sponsor and/or Lead Data Manager.
Run patient- and study-level status and metric reporting.
Perform medical coding of medical terms to ensure medical logic and consistency.
Coordinate SAE/AE reconciliation.
Liaise with third-party vendors, including external data and EDC vendors, in a project management capacity to support timelines and data-related deliverables.
Assist with SAS programming and quality control of SAS programs used in the Data Management department, as needed.
Identify and troubleshoot study operational problems, issues, obstacles, and barriers using metrics data, audit reports, and input from project team members and stakeholders.
Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by a project.
Participate in developing and maintaining SOPs and process documentation related to data management and database management activities.
Attend strategy meetings, bid-defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings as needed.
Review Requests for Proposals and proposals, and provide project estimates as needed.
Train data management project team members and ensure they have been sufficiently trained.
Communicate with study sponsors, vendors, and project teams about data, database, and other relevant project issues.
Present software demonstrations and trainings, department or company training sessions, and project meetings as needed.
Travel occasionally as required.
Perform other duties as assigned.