Clinical Data Manager
Position Title: Clinical Data Manager
Position Type: Full Time
Job Type: Experienced
Reporting To/Department: Senior Director of Clinical Affairs
Location: Local hires only (must have ability to commute to Newton, MA)
Lumicell is seeking a highly motivated Clinical Data Manager to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated outstanding clinical data from multiple cancer indications. Lumicell is currently conducting a Pivotal trial (similar to a Phase III drug trial) in our lead indication of breast cancer.
This position will support all aspects of the clinical trial program, including Feasibility/Phase I/Phase II studies through Pivotal/Phase III studies in multiple cancer indications for to support PMA and NDA market applications for our combination product (device/drug).
- Responsible for oversight and execution of data management activities for assigned clinical trials including data timelines and key deliverables
- Manages and supports vendors contracted to assist in the conduct of the clinical trial, including, but not limited to CROs, Labs, ePRO, and IRT
- Prepares reports, data charts and other presentation materials as needed
- Responsible for executing data cleaning activities: including generating and managing clinical trial data queries, management of coding for specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events
- Supports coordination of randomization procedures and blinding
- Manages external review of medical and safety data
- Contribute to preparation of reports and analyses reflecting study progress, enrollment trends and appropriate recommendations and conclusions
- Generates listings of data entry and monitoring progress to support clinical trial management and source data verification
- Responsible for data management documents in eTMF
- Supports continuous improvement in data management processes
- Experience with Electronic Data Capture (EDC) system(s) is required, Medrio preferred
- Manages data management CRO and oversees database development, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines, data management plan development according to ICH/GCP/CFR guidelines and other current regulatory requirements and best practices
- Leads eCRF design
- Manages database change controls including risk assessments and oversight of implementation
- Familiarity with data standards is required
- Oncology or imaging experience preferred
- B.A. or B.S. in a science related/health field or related work experience is helpful.
- Proven ability to use all MS Office suite programs
- Demonstrates a working knowledge of ICH GCP regulations
- A minimum of 5 years’ experience working as a Clinical Data Manager in the life science/pharmaceutical/medical device industry, or an equivalent combination of training and experience in clinical data and or a related field, with particular skills and knowledge working on clinical trials following FDA/ICH guidelines.
- This position does not currently have supervisory responsibilities over other managers.
- This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones
- Lumicell has an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site.
- Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.
Position Type/Expected Hours of Work
- This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand
- Some travel may be expected for this position including internal meetings, conference and or training events
- Lumicell is an equal opportunity employer
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
To apply for this position, please send your resume to email@example.com.