Company Summary :
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 being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.
2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.
2 / CD137 and GDF15. For more information about Leap Therapeutics, please visit .
General Responsibilities :
The Senior Director, Clinical Data Management is accountable for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH / GCP.
This role manages the CDM function, ensuring the development and readiness of personnel to deliver on existing programs while also being forward-looking and innovative.
Responsible for performing data management oversight activities in support of Leap Clinical Studies by overseeing the activities of the CRO DMs, from study start-up through to study closeout, to ensure adherence to scope of work and service agreements, and that the deliverables are on time, within budget and are of a high quality.
This role is expected to lead multiple clinical programs, manage a couple of direct reports and multiple clinical studies (3 to 5), and oversee multiple CRO / vendors.
Specific Responsibilities Include :
- Provide a high level of expertise and guidance in data management to support clinical studies.
- Promote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency.
- Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH.
- Prepare budget forecast and management of CDM budgets, timelines, and resources.
- Collaborate with other functions to develop project / study timelines and maintains internal data management timelines.
- Provide leadership and direction for outsourced activities including quality control and budget
- Ensure 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.
- Provide 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.
- Establish data transfer guidelines / agreements for external data with CROs and external data vendor partners; ensure transfers and reconciliations are to plan.
- Review and contribute to 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.).
- Lead and oversee the design, the creation and perform Sponsor User Acceptance Testing (UAT) activities for clinical trial study database builds and any subsequent database modifications.
- Lead and drive the internal data review process in collaboration with the Leap study teams to ensure data quality. Define the data listings needed in support of the data review.
Ensure all identified issues are documented appropriately and followed to resolution / completion.
- Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents.
- Provide 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.
- Ensure coordination with Pharmacovigilance on serious adverse event reconciliation.
- Work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed as per study timeline.
- Participate or assist in initiatives and in the development, review, implementation and maintenance of processes and SOPs related to clinical data management activities.
Supports cross-functional process definition, innovation and optimization.
- Participate in audits and inspections. May assist in performing a functional assessment of data management CROs / vendors.
- Manage a couple of data managers and / or contractors.
Education / Experience / Skills :
- BA / BS in scientific or health related field.
- 12+ years data management experience in a pharmaceutical, biotechnology company or a CRO.
- Oncology experience is required.
- 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.
- Effective verbal and written communication skills and interpersonal skills are required.
Senior Clinical Data Analyst
Overland Street, Boston, MA 02215....
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