Manager, Data Management

About Edgewise Therapeutics

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

Position Summary

This position will serve as the in-house Data Manager responsible for providing oversight to the CRO Data Management team for their assigned studies. This role will consult and collaborate with all functions within the clinical development team, as necessary and report into the Head of Data Management.

Responsibilities

• Manage the performance of Contract Research Organizations (CRO) responsible for data management activities
• Responsible for overseeing all DM activities from start-up, conduct, and closeout including CRF and EDC development
• Lead/drive project deliverables and timelines
• Review and approve clinical trial documentation, including timelines
• Perform data cleaning and external vendor data reconciliation
• Collaborate with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other departments on clinical trials
• Participate/lead in data management and cross-functional project clinical trial meetings
• Develop and communicate metrics, to internal and external teams to ensure achievements are met
• Perform other duties as needed to ensure data quality
  
  
  

Required Qualifications

• B.S. in a scientific field with a minimum of 5years leading data management activities. CRO experience required pharma/biotech experience a plus
• Proficient in clinical data collection, cleaning, and analysis for clinical trials; rare disease / neuromuscular and / or pediatrics experience is preferred
• Experience working in an outsourced Data Management model
• Experience with EDC systems is required
• Solid understanding of ICH GCP as well as general knowledge of industry practices and standards (CDASH, SDTM)
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
  
  
  

Additional Qualifications

• At least 2 years’ experience as a Lead/Program Data Manager preferred
• Interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills
• Ability to self-motivate and lead with confidence is critical
• Excellent organizational and time management skills, sense of urgency
• Strong analytical and problem-solving skills
• Project Management skills
  
  
  

This is a remote position

Salary range: $125,000-$185,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.