Clinical Data Standards Jobs (NOW HIRING)

You are a strategic and hands-on leader who is energized by rolling up your sleeves alongside your team, not just directing from a distance. You are willing to step into details whenever needed. You translate strategy into concrete, actionable plans with clear owners, timelines, and milestones. You are a sharp, critical thinker who anticipates issues before they become crises and brings pragmatic, well-reasoned solutions to the table. You care about the science behind the trial, not just the data, and understand how data management decisions affect downstream analysis, medical review, and submission timelines. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, effectively build working relationships inside and outside of the company.

This individual will report to the Head of Biometrics and lead clinical data management across multiple drug development programs, including the development and implementation of data standards. This is a player-coach role: the Director is expected to set DM strategy and data standards, be responsible for the generation of multiple data sets and systems, build upon and lead the existing, high-performing DM function, and partner effectively with our CRO partners to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

• Provide expertise and contribute to the strategy and development of the Clinical Data Management Systems to ensure data quality in support of clinical study data milestones and deliverables
• Directly manage, mentor, and develop internal DM staff, and provide day-to-day oversight and leadership of data management personnel at CRO partners, holding both internal staff and vendors accountable to quality and timeline commitments
• Lead and support establishment of systems and processes to help ensure clinical data security and integrity. Own end-to-end DM deliverables across the program portfolio.
• Develop and oversee the Data Management Plan, database design, edit check specifications, and CRF completion guidelines, ensuring adherence to CDASH, SDTM, and ADaM standards, and quality and consistency across studies.
• Stay current on emerging technologies and industry best practices in clinical data management, and proactively evaluate opportunities to apply AI and automation to improve data quality, efficiency, and speed to database lock
• Drive standardization and continuous process improvement initiatives through to completion, with defined action plans, milestones, and measurable outcomes
• Serve as the primary point of contact for DM matters for the Head of Biometrics and cross-functional leadership internally, and with CRO/vendor partners, auditors, and regulatory agencies externally
• Lead CRO/vendor selection, contracting input, ongoing oversight, and performance/budget management for outsourced data management activities
• Own inspection and audit readiness for Clinical Data Management, and represent DM directly during regulatory inspections and audits
• Proactively identify data quality, timeline, and vendor-performance risks; bring forward clear, actionable mitigation plans rather than open-ended concerns
• Represent DM on cross-functional project and submission teams, and communicate DM strategy, status, and risks clearly and concisely to senior leadership

At 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:

• BS in computer science, or a science-based subject (advanced degree a plus), with 10+ years of clinical data management experience in industry, including several years directly managing people and/or CRO data management teams
• Strong critical thinking and sound judgment, with a consistent record of turning problems into concrete, actionable plans
• Strong CRO vendor management, oversight, and budget management experience
• Proficient in Medidata RAVE and other EDC platforms; programming experience is a plus
• Experience with CluePoints, Spotfire or similar data review/analytics tools
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Strong understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
• Experience with regulatory GCP inspections/audits preferred
• Exceptional written and verbal communication skills, with demonstrated success communicating clearly and credibly with senior leadership, cross-functional partners, CRO/vendor partners, and regulators
• Desire to work in a collaborative, fast-paced, and innovative environment
• 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.

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.

But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.

At Entrada, our approach to compensation is grounded in transparency, equity, and performance, recognizing the unique contributions each person brings. We believe meaningful work deserves meaningful reward, and view compensation as one way to show appreciation for the collaboration, curiosity, and commitment that drive our mission forward.

The salary for this opportunity ranges from $219,000 - $244,500. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote