Director, EDC Operations

Company Profile:

At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan.

We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

Verastem is looking for an experienced Medidata Certified RAVE EDC leader and builder to be responsible for all EDC activities across multiple clinical programs.  This is an exciting opportunity to expand our in-house EDC capabilities by building on a solid, established foundation. Experience with  EDC designs, builds, and maintenance of electronic data capture (EDC) systems for phase 1-3 oncology trials using Medidata RAVE, creating eCRFs, edit checks, and custom logic, ensuring data integrity, and collaborating with study teams to meet protocol & regulatory needs, proficiency in design, build, and reporting features.  We have a short timeline and high expectations; if you have a high capacity for work and are looking to contribute to a very talented clinical team, Verastem is the place for you.

Responsibilities

• Oversee all EDC build activities from study start-up through database lock, as performed in-house or outsourced, working closely with the head of data management.
  • Develop programming/configuration of RAVE, folders, edit checks, custom derivations, integrations (including IRT, pharmacovigilance, data visualization), migrations, and reports, based on protocol requirements.
• Set up Coder, Local Lab, RTSM, Targeted SDV modules, and any other applicable modules.
• Lead eCRF design and review meetings.
• Provide user support and technical support.
• Conduct end user training as appropriate
• Work collaboratively with Head of Data Management
• Lead, oversee and work effectively with vendor partners in user acceptance testing and deployment.
• Troubleshoots and resolves technical issues in a timely manner.
  • Lead the defining, writing and updating of Rave CDMS SOPs. Establish work plans and best practices in conjunction with other functions including (but not limited to): quality, IT, data management
• Develop and carry out plans to transition EDC activities from vendor(s) for selected studies as appropriate
• Represent EDC activities, timelines, and deliverables at internal cross functional team meetings and meetings with external vendors
• Support GCP inspection readiness.


Qualifications

• BA/BS in scientific or health care field preferred, with at least 10 years related experience in EDC systems/data management in the pharmaceutical/biotechnology/ CRO setting;
• Expert knowledge of EDC systems (including Medidata RAVE EDC/Classic platform) experience building and designing efficient EDC data management systems;
• Proficiency in understanding links between EDC and other Clinical Trial/Data Management Systems;

• Understanding of clinical trial processes and data management.
• Certified Medidata RAVE builder; Knowledge of SQL required.
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH;
• Overall understanding of ICH, GCP as well as general knowledge of industry practices and standards. Experience in oncology indication strongly preferred;
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11;
• Knowledge of coding dictionaries (MedDRA, WHO Drug); familiarity with medical terminology preferred;
• Excellent verbal and written communication skills as well as interpersonal and organizational skills;
• Strong attention to detail & problem-solving, ability to prioritize and handle multiple projects;
• Proficiency in MS Office applications

 The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.