Data Management Director jobs in Washington

The Director, Clinical Data Management will lead Data Management for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director, Clinical Operations, the incumbent will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout and be responsible for the oversight and management of clinical data management activities outsourced to CROs.

• Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to the scope of work and service agreements.
• Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners.
• Responsible for CRO adherence to project timelines, from study startup through study closeout, ensuring high quality and integrity of all deliverables.
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
• Review data via listings and visualization tools to report on performance and quality; review will be performed with clinical data within studies and across multiple studies for trend analysis.
• Contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs.
• Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
• Participate in vendor qualifications and audits.
• Oversee the planning, execution, and maintenance of major projects and initiatives, if required.
• Lead data management study inspection readiness activities and support of submission activities as needed.
• Train and mentor DM staff or members of the clinical trial team on processes, projects, systems, and programs.
• Perform hands-on data management responsibilities, if required.

• Bachelor's degree in science or related area (or equivalent); Masters or Advanced Degree preferred.
• 10 years of experience in clinical data management experience in biotech/ pharma industry; significant end-to-end, hands-on experience in all aspects of data management.

• Experience with phase global phase III clinical trials for a biotechnology company, preferably with Vaccines.
• Experience in Industry Standards (e.g., CDISC) in the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
• Experience with Medidata Rave (EDC) and Metadata Repository (MDR) is preferred.

• Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
• Strong organizational skills, attention to detail, and self-motivated.
• Vendor management experience.
• Experience in creating all components of a submission package.
• Team player, with the ability to work successfully across functions.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $ 110,000 - $180,000 annually. The salary range may vary based on Curevos compensation practices and an applicants qualifications and experience.

Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevos Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.

At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.