Shattuck Labs, Inc. (www.shattucklabs.com) is developing breakthrough therapies for immunotherapy, which harnesses the human immune system to improve survival for patients battling cancer and inflammatory disease. Shattuck has pioneered the development of dual-sided Fc fusion proteins with the Agonist Redirected Checkpoint (ARC) platform technology. Two compounds from the platform are currently being tested in clinical trials (SL-172154 and SL-279252). In multiple published studies, ARC therapeutics have significantly outperformed traditional antibody-based therapeutics, and we believe that the dual-functionality of the ARC platform positions our product candidates with best-in-class potential as compared to traditional antibody therapeutics. Over 300 product candidates have been generated from the ARC platform and are poised for IND-enabling studies. Shattuck’s R&D and clinical operations are based in Durham, NC, and its corporate offices are in Austin, Texas.
About the Position
the clinical data management function at Shattuck Labs to ensure the integrity,
accuracy and quality of clinical study data and to deliver high quality data
package within the agreed upon timelines. Serve as the expert in end to end
clinical data management activities, provide oversight and advice to clinical
team regarding clinical data management activities and deliverables. Help to
select, coordinate and manage external vendors supporting clinical data
management. Maintain and improve professional knowledge of technological
advancements in clinical data management. Train and manage staff (internal,
contract, CRO) to support the clinical data management team as the organization
Summary of Key Responsibilities
- Engage with clinical teams across the company’s portfolio and provide subject matter expertise. Serve as the lead clinical data manager for clinical studies and responsible for clinical data management activities from CRF development to database lock. Lead clinical team to review data management documents and perform user acceptance testing. Manage clinical data cleaning, regular clinical data review, and other data management activities up to and including database lock. Review clinical data to ensure accuracy, quality and integrity of data. Generate, resolve, and track queries to address discrepant data identified during the review. Coordinate data transfer (clinical data and vendor related data). Perform data reconciliation as needed. Proactively ensure on-time delivery through monitoring of study timeline.
- Provide oversight and supervision of relevant external consultants and clinical research organizations for outsourced clinical data management activities. Oversee all clinical data management activities conducted by clinical research organizations (CROs) including but not limited to development of data management plan, CRF specifications, CRF, data validation plan, edit checks/custom functions, CRF completion guidelines, and SDTM dataset. Ensure CRF, database and datasets are set up per study specific requirements.
- Evaluate workloads, resources, process, and technology, and prioritize projects/deliverables for efficient operation of the clinical data management function. Ensure systems are in place to produce quality work efficiently.
- Development of clinical data management operating procedures as needed.
- Engage in regulatory submission as needed. Participate in the preparation of publications including manuscripts, posters and oral presentations for clinical data management support.
- Minimum of a BS in a science degree and/or equivalent experience.
- 10+ years industry experience in clinical data management; previous experience of regulatory submissions is preferred.
- Ability to manage several programs and protocols.
- Experience in early phase oncology clinical trials including RECIST criteria.
- Experience with clinical data management systems and electronic data capture (EDC).
- Experience in CDISC standard including SDTM data standards.
- Management experience including managing external vendors/partners.
- Experience with EDC and CRF development.
- Experience in clinical data management for oncology clinical trials.
- Good communication and interpersonal skills and ability to work with cross-functional teams.
- Positive and collaborative attitude.
- Deeply motivated self-starter with an entrepreneurial spirit.
- Good team player.
- Ability to work in a quickly changing, fast-paced environment, and to adapt and adjust to changing priorities.
- Unrelenting dedication to delivering high quality results.
- Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently.
- Willing to roll up your sleeves to get the job done.
Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.