Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap has a strong financial position and in September 2021 closed a public offering with gross proceeds to Leap of approximately $104 million. Leap is based in Cambridge, MA. For more information about Leap Therapeutics, visit http://www.leaptx.com
- Responsible for the oversight of clinical data management activities outsourced to CROs, from study start-up through to study closeout, ensuring high quality data deliverables which are on time and within budget. This role is expected to lead a multiple clinical programs, manage multiple clinical studies (3 to 5) and . multiple CRO/vendors.
Specific Responsibilities Include:
• Establishes data management strategy at the project and/or study level for multiple projects/studies. Proactively identifies and manages risks.
• Ensures data management deliverables meet/exceed project/study team expectations regarding quality, time and cost, plus data management documentation is filed/archived according to applicable company and regulatory requirements.
• Collaborates with other functions to develop project/study timelines and maintains internal data management timelines.
• Provides oversight for data management CROs and other third-party vendors who provide clinical study data to ensure compliance with the protocol, external/internal procedural standards, GCP, applicable regulatory guidelines, company policies, SOPs and other relevant guidelines. Acts as the primary liaison with DM CROs, third party vendors and EDC vendors for study work.
• Establish data transfer guidelines/agreements for external data with CROs and external data vendor partners; ensure transfers and reconciliations are to plan.
• Reviews clinical study related documents from a data management perspective (e.g. protocol) and approves DM specific documents (e.g. Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.).
• Leads and performs User Acceptance Testing (UAT) activities for clinical trial study database builds and any subsequent modifications.
• Leads and drives the internal data review process in collaboration with the Leap study team to ensure data quality. Defines the data listings needed in support of the data review. Ensures all identified issues are documented appropriately and followed to resolution/completion.
• Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes. May train other personnel on data management related items as needed, e.g., eCRF, EDC system.
• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
• Works with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed as per study timeline.
• May participate or assist in the development, review, implementation and maintenance of processes and SOPs related to clinical data management activities.
• Participates in audits and inspections. May assist in performing a functional assessment of data management CROs/vendors.
Education / Experience / Skills:
• BA/BS in scientific or health related field.
• 7+ years in data management experience in the pharmaceutical, biotechnology or in a CRO.
• Oncology experience preferred.
• Significant experience of using data management methodologies and technologies (e.g., familiar with multiple EDC systems: IBM CD, Rave, etc. ).
• Experienced with CDISC data standards, in particular, CDASH and SDTM.
• Demonstrated ability to manage multiple projects/studies. Strong project management skills.
• Demonstrated understanding of regulations and guidelines (e.g., ICH, GCP, FDA, Privacy rules [HIPAA], etc.).
• Ability to work in a cross-functional team-oriented environment.
• Ability to read, analyze and interpret complex technical documents. Effective problem-solving skills.
• Experience using Microsoft Office applications (Word, Excel, PowerPoint, Microsoft Project, etc.)
• Strong organizational skills and the ability to prioritize tasks. Flexible to changing priorities, and detailed oriented with initiative to take on unfamiliar tasks.
• Strong attention to detail.
• Comfortable in a fast-paced small company environment with minimal direction.
• Possess effective verbal and written communication skills and interpersonal skills are required.
• <5% travel.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.