Manager, Clinical Data Management (00045)

ABOUT ASCENDIS PHARMA, INC.

Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany, Princeton, New Jersey, Redwood City, and Palo Alto, California.

Duties: Lead data management activities of Phase 1 through Phase 4 clinical trials for assigned studies in oncology, endocrinology, and future therapeutic areas following International Conference on Harmonization (ICH)/Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and other relevant industry standards. Serve as primary clinical data management representative on cross-functional project teams and as the point of contact with CROs to ensure study deliverables and timelines are met for assigned studies. Lead eCFR design and lead activities with external vendors relating to development and validation systems and applications for clinical trial data collection to ensure quality and timely deployment. Manage and review data transfers for assigned studies. Generate, review, and approve study documents (Data Management plans, data transfer specifications, SAE and data reconciliation plans, etc.). Ensure clinical data submissions meet regulatory standards. Generate and implement Clinical Data Management Plan (CDMP) and Data Review Plans (DRP) to enable quality review of patient data supporting filings, publications, and other business activities. Participate in ongoing development, review, and revision of Standard Operation Procedures (SOPs) and standard CDM templates. U.S. domestic travel required to Palo Alto, California HQ 1-2 weeks a year. May work full-time remote from anywhere in the U.S.

Requirements

Minimum requirements: Master’s or Bachelor’s degree (U.S. or foreign equivalent) in Biotechnology, Computer Science, Computer Information Systems, or a related technical or biotechnical field. Must have three (3) years of experience (with Master’s) or five (5) years of progressive, post-baccalaureate experience (with Bachelor’s) in job offered or related clinical data management role. Prior experience must include three (3) years of experience in/with: overseeing clinical data management study processes, including gathering, cleaning and managing data; managing clinical data management deliverables throughout phases 1-4 of clinical trial studies; adhering to regulatory requirements and industry standards, including ICH, GCP and GCDMP; working with one or more electronic data collection (EDC) platforms such as an Interactive Response Technology (IRT) platform or Electronic patient-reported outcomes (ePRO) platform; EDC configuration using Veeva Vault CDMS, Medidata Rave eClinical Outcomes Assessment (eCOA) software or similar. U.S. domestic travel required to Palo Alto, California HQ 1-2 week a year. May work full-time remote from anywhere in the U.S. Salary: $165,000 to $170,000/year, M-F, 40 hours/week.

#IND-DNS

JOB TYPE: Regular

PRIMARY LOCATION: U.S. Remote

ORGANIZATION:

SCHEDULE: Full-time

SHIFT: Day

TRAVEL: U.S. domestic travel required to Palo Alto, California HQ 1-2 week a year.

Ascendis is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action-Employer, making decisions without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, marital status, protected veteran status or any other protected class.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance