Entrada Therapeutics · 1 day ago
Manager, Clinical Data Management
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients through innovative medicines. The Manager, Clinical Data Management will lead clinical data management activities for clinical trials, overseeing project management and ensuring quality and standardization of data deliverables.
BiotechnologyEmergency MedicineGeneticsHealth CareMedical
Responsibilities
Oversee and lead data management personnel at the CRO, ensuring the deliverables are aligned with business needs and timelines
Author, review, and revise related study plans, including Data Quality Management Plans, Data Validation Plans, Data Review Plans, eCRF Completion Guidelines, and other study documents to ensure quality and standardization
Represents Data Management on cross-functional project teams
Work closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports
Participating in the preparation of clinical study reports and other regulatory documents
Work with the clinical team to define study data review plan specifications
Prepare and provide data listings and reports as required (e.g. leadership reporting, DMCs, etc.)
Provide review and guidance to protocol development as it relates to data collection and management
Lead the study team's activities regarding data management throughout the study lifecycle, from planning to start-up, conduct, and close-out
Accountable for creating and delivering Data Management documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.) and ensure documentation is appropriately filed within the Trial Management File (TMF)
Lead or support the development of contracts with external vendors for data collection, cleaning, and reporting, and review the Scope of Work related to data management responsibilities
Partner with internal functional teams to manage and coordinate data collection and maintenance with external vendors to ensure deliverables and project milestones are being met
Qualification
Required
Bachelor's Degree in a Science-related or technical field or a similar area of focus and a minimum of 6 + years of experience within the biotech or pharmaceutical industry
Experience with the full Clinical Data Management activity life cycle (start-up, maintenance, and closeout)
Established knowledge and experience working with Medidata Rave EDC
Knowledge of MedDRA and WHODrug coding, with experience overseeing coding and SAE reconciliation activities for clinical trials
Strong documentation and organizational skills, as well as a proven ability to be self-motivated and able to work independently
Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders
Preferred
This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA
Benefits
Comprehensive health, dental and vision coverage
Life and disability insurance
401(k) match
Paid, gender-inclusive parental leave
Holistic support for your health and well-being
Education reimbursement
Discretionary time off
Commuting benefits aligned to your working model
Company
Entrada Therapeutics
Entrada Therapeutics is a developer of novel therapeutics intended to treat devastating diseases.
H1B Sponsorship
Entrada Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (14)
2023 (4)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$301.6MKey Investors
Wellington Management
2024-06-24Post Ipo Equity· $100M
2022-12-08Post Ipo Equity· $26M
2021-10-29IPO
Recent News
BioWorld Financial Watch
2026-01-11
2025-12-17
Company data provided by crunchbase