Turnstone Biologics is a clinical stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach with a clinically validated technology, tumor infiltrating lymphocyte (TIL) therapy. Turnstone’s innovative TIL therapy, which is designed to extend the efficacy of TILs to multiple solid tumor indications by selecting and manufacturing the most potent tumor-reactive T-cells (Selected TILs) for tumor eradication, represents the Company’s foundational therapeutic modality driving its cancer immunotherapy pipeline. The Company recently commenced two clinical trials in various solid tumor types with its lead Selected TIL therapy candidate, TIDAL-01, one of which is in collaboration with Moffitt Cancer Center. Turnstone is developing additional strategies to further potentiate the clinical benefit of Selected TILs, including use in combination with their novel viral immunotherapy.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’. If you are a passionate person, and our science excites you – this opportunity may be for you.
The Director, Clinical Data Management & Biostatistics will take the data management lead on outsourced Phase I/II/III studies. Since the studies are outsourced, the individual will provide vendor management oversight including biostatistics services and strategic biostatistics consultants as well as review of DMPs, CRFs, DVS, perform UAT, etc. The individual must be an experienced Data Manager who is able to work independently and cross functionally. This individual must be self-motivated and collaborative amongst internal stakeholders as well as external and CRO partners as appropriate.
- Responsible for assessing in house data management needs and driving the selection and implementation of any in-house data management solutions including developing policies and procedures
- Responsible for clinical data management activities for outsourced studies
- Ensures data management activities for clinical trials within assigned research program(s) are completed in a timely and accurate manner
- Leads statistical and programming vendors to plan and implement statistical and programming project plans
- Develops proposal requests to service providers; evaluates and approves service level agreements
- Oversees service providers to perform core data management functions including IWR/IVRS, CRF, edit check and CRF completion guidelines development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures
- Works collaboratively with Biostatistics and Programming during data integration leading up to a regulatory filing
- Establish inter- and intradepartmental processes to improve the efficiency and quality of data processing
- Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
- Develops positive partnerships with CROs and ensure a high standard of deliverables are maintained.
- Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
- Prepares and maintains timelines for the assigned studies and communicates to management any issues so that appropriate actions can be taken.
- Prepares status reports and updates for data management as required
- Collects and monitors study metrics
- Plans and oversees preparation of safety committee data management as well as annual report data management Approves data management plans for completeness and accuracy of required documentation
- Oversees, review of the DMP and other pertinent documents for all assigned studies.
- Oversees and performs UAT on CDMS components as needed.
- Provides input into CDMS requirements, assuring protocol requirements are met.
- Supports validation efforts to minimize the company’s exposure to regulatory risk by validating all electronic data streams and systems in support of organizational objectives
Skills, Qualifications, And Requirements
- BS Life Sciences or Computer Science
- 8-10 years of data management experience in a clinical research setting
- Strong working knowledge and prior experience directly managing/overseeing service providers and CRO’s is required
- Prior experience managing clinical data for multiple studies at one time
- Experience with computerized clinical data management systems is required
- Knowledge of SAS and database programming
- Systems integration experience
- Understanding of CDASH and CDISC standards
- Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
The anticipated salary range for this role is $175,000 - $210,000
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.