Manager, Clinical Data Management

Company: Initial Therapeutics, Inc.
Location: Boston
Posted on: February 20, 2025

Job Description:

The OrganizationWhat's happening at Entrada Therapeutics? 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-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological 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.We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.The Perfect Addition to Our TeamYou 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 OpportunityThe Manager, Clinical Data Management, is an integral part of the Clinical Data Management (CDM) team. This individual will report to the Associate Director, Clinical Data Management, 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.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.
• Represent Data Management on cross-functional project teams.
• Work closely with biostatisticians and other data scientists to analyze clinical data and generate statistical reports.
• Participate 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.The NecessitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
  • Humanity - We genuinely care about patients and about one another.
  • Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
  • Creativity - We are creative problem solvers.
  • Collaboration - We are more than the sum of our parts.
  • Curiosity - We have a growth mindset and push conventional thought and theory.To thrive on our team, you will need to come with:
    • 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. #LI-Remote #LI-JF1The PerksBy becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work-life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
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Keywords: Initial Therapeutics, Inc., Boston , Manager, Clinical Data Management, Healthcare , Boston, Massachusetts