Associate Director, Clinical Data Management
4 days ago
What'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 and 50 skipping amenable. We have also 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 Team
You are excited about the opportunity to lead and support clinical data management and the progress of our 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.
The Opportunity
This individual will report into the SVP of Clinical Operations and support the clinical data management across multiple drug development programs including the development and implementation of data standards. They will be responsible for the generation of multiple data sets and systems, partnering 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.
Responsibilities
- 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
- Oversee and lead data management personnel at the CRO, ensuring the deliverables are aligned to the business needs and timelines
- Lead and support establishment of systems and processes to help ensure clinical data security and integrity
- Develop and/or write the database design, edit checks, CRF completion guideline, and Data Management Plan for in-house data management activities ensuring CDASH, ADaM, and SDTM standards
- Work cross functionally to standardize data collection and reporting
- Standardize and manage the clinical data flow process to data delivery for analysis purposes
- Lead and/or contribute to standardization and process improvement initiatives
- Author, review, and revise related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Represents DM on cross-functional project teams & submission Teams.
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.
- BS in computer science, or a science-based subject with 8 + years of clinical data management experience in industry, with experience across various indications and EDC platforms.
- Strong CRO vendor management and oversight experience
- Solid technical skills across data platforms; programming experience preferred
- Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
- Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
- Experience in regulatory GCP inspections/audits preferred
- Experience with CluePoints, Spotfire, eluminate or other data softwares
- Excellent verbal and written communication skills
- Desire to work in a collaborative and innovative environment
The Perks
By 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.
Third Party Staffing Agencies
Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy Statement
Entrada Therapeutics, Inc. (the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.
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