Manager, Clinical Data Management

Entrada Therapeutics•Boston, MA

2d•$138,000 - $166,000•Remote

About The Position

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. You are excited about the opportunity to lead clinical data management activities for clinical trials here at Entrada. You are well organized and understand how to navigate different types of clinical data sets. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company. You bring the ability to Inspire innovations and problem solving by seeking to improve how work gets done, and you inspire other team members to do the same. The Manager, Clinical Data Management, is an integral part of the Clinical Data Management (CDM) team. This individual will report to the Senior Director, Biostatistics, and will lead clinical data management activities across multiple studies. They will be responsible for day-to-day oversight and project management for CDM activities, including EDC development, implementation, and maintenance; data review and query management; vendor management; and the coordination and execution of data deliverables.

Requirements

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.
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.

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.