Manager Clinical Data Management
Manager Clinical Data Management
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Job Description
The Organization
Whats happening at Entrada Therapeutics Entrada is a clinicalstage 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 enzymebased 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 clinicalstage program VX670 for myotonic dystrophy type 1.
We are a tightknit 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 highenergy 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 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 fastpaced 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 Opportunity
The 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 daytoday oversight and project management for CDM activities including EDC development implementation and maintenance; data review and query management; vendor management; and the coordination and 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.
- Represents Data Management on crossfunctional 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 teams activities regarding data management throughout the study lifecycle from planning to startup conduct and closeout.
- 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 Necessities
At Entrada our passion for science our devotion to patients and our values drives ourbehavior:
- Humanity We genuinely care about patients and about one another.
- Tenacity We are relentless and persistent in the pursuit of developing therapiesfor 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:
- Bachelors Degree in a Sciencerelated 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 (startup 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 selfmotivated 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. #LIRemote #LIJF1
The Perks
By becoming a team member here at Entrada youll have access to competitive health dental and vision coverage as well as life insurance and short term and longterm disability insurance. We value work life balance youll 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.
Required Experience:
Manager
Employment Type
Full Time
