Senior Clinical Data Manager

COMPANY

Volastra Therapeutics, Inc. is a clinical-stage oncology biotech company based in New York City, pioneering novel approaches to treating cancer by targeting chromosomal instability (CIN), a unique vulnerability in cancer. Since its founding in 2019, Volastra has grown to support ongoing discovery efforts and a growing clinical organization.

Our lead pipeline programs focus on two distinct inhibitors of KIF
18A, a novel therapeutic target. VLS-1488, internally discovered, entered clinical trials in Q4 2023 for the treatment of advanced cancers. Sovilnesib, in-licensed from Amgen in 2023, re-entered the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets.

Volastra is backed by top US and European venture firms such as Arch, Polaris, Vida, Droia, Catalio, and B Capital, alongside strategic investment from Eli Lilly. In addition to venture funding, Volastra has established partnerships with oncology leaders. Our senior leadership team is highly experienced, supported by a world-class advisory board.

We are headquartered in West Harlem, New York City, within easy reach of Columbia, Cornell, Memorial Sloan Kettering, and surrounding areas. Please visit  for more information.

JOB DESCRIPTION:

Volastra Therapeutics is seeking a Senior Clinical Data Manager to join our growing Clinical team. This is a newly created role and will be a key individual contributor with ownership of clinical data management activities for early-phase oncology trials.

The ideal candidate brings hands-on experience in oncology clinical data management, deep familiarity with Medidata Rave and the ability to work cross-functionally in a fast-paced biotech environment.

Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization.

This role is based in New York City and requires a minimum of one day per week in the office.

RESPONSIBILITIES:

* Own and manage clinical data management activities for assigned early-phase oncology studies, ensuring data quality, integrity, and inspection readiness.

* Serve as the primary owner and administrator of the company's Medidata platform, including Cloud Admin configuration and maintenance, user access management, etc.

* Provide oversight of EDC builds and updates, including review and approval of database specifications and edit check specifications, completion of UAT, etc.

* Develop and implement data review plans and coordinate ongoing external and internal data cleaning and query management activities.

* Review data listings to support study oversight and decision-making.

* Collaborate cross-functionally with Clinical Operations, Clinical Science, Biostatistics, Medical, and external vendors/CROs to ensure alignment and timely data delivery.

* Monitor data management metrics and reports to ensure compliance with protocols and study plans.

* Contribute to process improvement, SOP development, and inspection readiness activities as the clinical organization continues to scale.

REQUIREMENTS

* Bachelor's degree in life sciences, data science, or a related field.

* 6+ years of clinical data management experience, with at least 3 years in oncology clinical trials.

* Prior experience in early-phase (Phase 1/1b/2) oncology trials within a biotech or CRO setting.

* Extensive hands-on experience with Medidata including Cloud Admin and Rave EDC.

* Elluminate administration experience a plus

* Strong understanding of CDISC standards.

* Experience working with CROs and vendors, including oversight of outsourced data management activities.

* Working knowledge of GCP, ICH, and regulatory expectations for clinical data.

* Highly detail-oriented with strong organizational and problem-solving skills.

* Adaptable mindset with interest in helping build and scale data management capabilities.

SALARY RANGE:

Base salary approximately $140,000 - $160,000 which may vary depending on qualifications, experience, and ultimate leveling.