Clinical Data Manager II

Precision for Medicine

2d•$110,700 - $166,100

About The Position

The Clinical Data Manager II manages all aspects of clinical trial data management 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. The position may serve as the primary or contributing data management contact for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely completion of tasks. The Clinical Data Manager II develops and maintains study data management documentation, supports database build and testing, reviews clinical trial data, and coordinates with study sponsors, vendors, and project teams. The role may also contribute to department processes, project proposals and estimates, 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 with 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, and comprehend English fluently 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.
Must be legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Understanding of medical coding dictionaries, 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 coverage, 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 project timelines, ensure data management deadlines are met with quality, and assess resource needs when needed.
Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
Assist with clinical database builds; conduct database build user acceptance testing; maintain quality-controlled database build documentation; and oversee clinical database quality.
Specify requirements for electronic, manual, and other edit checks.
Create, revise, version, and maintain data management documentation, and oversee the completeness of data management documentation for the Trial Master File.
Train clinical research personnel on study-specific CRFs, EDC, and other project-related items as needed.
Review and query clinical trial data according to the Data Management Plan, and perform line-listing data reviews based on sponsor or Lead Data Manager guidance.
Run patient-level and study-level status and metrics reports.
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 manager 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 other stakeholders.
Assist with review and feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by a project.
Participate in developing and maintaining SOPs and related process documentation for 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 received sufficient training.
Communicate with study sponsors, vendors, and project teams regarding data, databases, and other relevant project issues.
Present software demonstrations or training, department or company training sessions, and project meetings as needed.
Travel occasionally as required.
Perform other duties as assigned.