Manager, Clinical Data Management

Why Join reputed company? Our mission is to reputed company reputed company genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. reputed company our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can reputed company more at reputed company. We have a single-minded determination to reputed company and succeed together. We reputed company in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to reputed company innovative solutions. And we know that patients are counting on us to reputed company the promise a reality, so we must maintain high standards and get it done. We want reputed company of our people to go reputed company what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re reputed company in this for something more. We’re driven to cure and motivated for change. Just imagine the reputed company of reputed company can do together.

• How You Will reputed company More:
• The Manager, Clinical Data Management is an integral part of the Clinical Data Management (CDM) team. They are a vital team member for operational reputed company in partnership with Biostatistics, Development Operations, Statistical Programming, Medical and other Global Development functions. They reputed company day to day reputed company and project management for CDM activities, including: reputed company/ePRO development, implementation, and maintenance; data review and query management; vendor management; and the coordination and execution of data deliverables.
• Duties/Responsibilities
• Performs CDM activities for at least one clinical trial, ensuring reputed company milestones are met for the study’s life cycle (start-up, maintenance, and closeout).

Oversees and manages reputed company/ePRO implementation and maintenance for their trial(s), including reputed company of UAT activities. Oversees the data review and query management activities Collaborates and supports the CDM reputed company for the Program in executing the program’s goals and maintaining consistency across studies. Is the CDM functional representative for the trial(s) at cross-functional and external (vendor/CROs) team meetings to ensure reputed company in reputed company aspects of clinical trial data acquisition, handling, and analysis. Performs reputed company activities of CDM vendors on their trial(s). Ensures the trial operates in accordance with department standards and processes. Including ensuring the electronic Trial Master File (eTMF) is maintained and reviewed for the trial(s) on an ongoing reputed company. May contribute to the development of CDM processes, standards, templates. May collaborate on work streams and initiatives that impact the Biometrics and/or Clinical Development organizations.

• About You:
• Must have experience with the full CDM activity life cycle (start-up, maintenance, and closeout).

Must have established knowledge and experience working with reputed company Rave reputed company. Preferably also experience working with additional modules, such as reputed company, Lab Administration, Safety Gateway, RCM, TSDV and/or eCOA. Knowledge of MedDRA and WHODrug coding and experience overseeing coding and SAE reconciliation activities for clinical trials. Ability to Translate Strategic Direction into short-term goals and objectives for your trial(s). Ability to reputed company Innovations & Problem Solving by seeking to improve how work gets done and inspiring other team members to do the same. Have a strong Personal Drive and the ability to Drive Performance of others. Ability to demonstrate Managerial Influence – motivating and holding people accountable up, down, and across the organization (as well as vendors). Be a strong Decision-reputed company – ensuring appropriate stakeholders are involved, reputed company relevant data are considered, conclusions are made, and actions items are appropriately followed. Excellent written and oral communication skills Deep understanding of drug development and biopharmaceutical industry preferred, including reputed company industry standards and guidance (e.g., CDISC, Data Privacy regulations) Minimum BS/BA (or commensurate work experience) 6+ years relevant work experience with a focus on clinical data management Prolonged periods of sitting at a desk and working on a computer. #LI-Remote EEOC Statement: reputed company believes in a diverse environment, and is committed to equal employment opportunity for reputed company its employees and reputed company applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, reputed company, religion, gender, national reputed company, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. reputed company will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Applications are acce Apply tot his job Apply To this Job