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About Us:

Timberlyne Therapeutics  is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne’s lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.

 Position Summary:

Timberlyne is seeking a Senior Manager/Associate Director of Clinical Data Management to join the Clinical Operations team.  This individual will be responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards, and act as a subject matter expert within the team.  They will be responsible for leading, planning and executing DM activities and deliverables across studies, overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for clinical trials to support both the internal stakeholders and external vendors, e.g., CRO’s.

Essential Responsibilities:

• Data management lead and primary contact on one or more studies.
• Work collaboratively with various stakeholders such as Clinical Development, Clinical Operations, Regulatory, and CRO vendors to provide guidance on clinical data management to study teams, vendors, and management and represents CDM in cross-functional meetings.
• Ensure DM project deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through study closure/archival.
• Apply effective vendor management and build strong sustainable relationships with multiple COR/vendors.
• Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning.
• Review, track, and report status of all data management project(s) to senior leadership.
• Proactively identify project challenges and risks and manage the escalation of study related issues and communicate as appropriate with management.
• Drive and lead the development of all data management activities including databases and eCRF design, development and implementation of database validation and UAT activities, definition and testing of edit checks, critical data management plans, manuals, guidelines and documents development and maintenance.
• Oversee data transfers set up and validation, including review of test data transfers for consistency with data transfer agreements.
• Oversea database lock and transfer process.
• Participate in study document reviews, e.g. Study protocols, Study Management Plans, statistical analysis plans (SAPs), etc.
• Perform supplemental data reviews, ensure quality checking and reporting according to the study data validation specifications or data review plans.
• Development of EDC custom report specifications, SAS Clinical Programming report specifications and/or associated outputs as needed.
• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF).

Skills and Experience:

• B.S. or B.A., advanced degree preferred, with 8+ years of relevant industry experience.
• Extensive knowledge and experience in clinical data management; Accountable for the data quality and data integrity for highly complex clinical studies.
• Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans. Comprehensive understanding of database and dictionary structures (MedDRA, WHO DRUG).
• Demonstrated experience in managing multiple CROs/vendors with CRO outsourcing model as well as in-house model.
• Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization).
• Proficiency in CDISC standards (CDASH, SDTM, ADaM), and deep understanding of clinical research regulations and guidance, including FDA CFR and ICH GCP.
• Strong interpersonal, communication (oral and written), and organizational skills.
• Logical thinking, attention to detail and accuracy, and comfortable adjusting workload based on changing priorities in a fast-paced small company.
• Strong communication and influencing skills.
• Ability to deal with time demands, incomplete information or unexpected events. 

How To Apply:  Please send your resume to careers@timberlyne-tx.com