Clinical Data Leader
Apply NowCompany: Treeline Biosciences
Location: Watertown, MA 02472
Description:
Clinical Data Leader
Treeline Biosciences
Treeline Biosciences, a clinical-stage biotechnology company, is seeking a skilled Clinical Data Leader to join our dynamic team. This role offers the opportunity to make a meaningful impact on cutting-edge research while ensuring compliance with industry standards and advancing best practices in data management.
About the Position
The Clinical Data Leader will play a central role in overseeing clinical data management activities to support the successful execution of clinical trials. The individual will collaborate with cross-functional teams, manage vendor/CRO activities, and ensure data quality and integrity throughout the clinical data lifecycle. The ideal candidate will have a strong understanding of clinical trial processes, regulatory guidelines, and technical systems, with a focus on delivering high-quality results aligned with Treeline's innovative research goals.
Responsibilities
Qualifications
Treeline Biosciences offers a dynamic and innovative work environment with opportunities to contribute to groundbreaking research. Join our team to make a meaningful impact on the development of life-changing therapies.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
Treeline Biosciences
Treeline Biosciences, a clinical-stage biotechnology company, is seeking a skilled Clinical Data Leader to join our dynamic team. This role offers the opportunity to make a meaningful impact on cutting-edge research while ensuring compliance with industry standards and advancing best practices in data management.
About the Position
The Clinical Data Leader will play a central role in overseeing clinical data management activities to support the successful execution of clinical trials. The individual will collaborate with cross-functional teams, manage vendor/CRO activities, and ensure data quality and integrity throughout the clinical data lifecycle. The ideal candidate will have a strong understanding of clinical trial processes, regulatory guidelines, and technical systems, with a focus on delivering high-quality results aligned with Treeline's innovative research goals.
Responsibilities
- Clinical Data Management:
- Lead the development of Data Management Plans (DMP), Data Transfer Plans/Agreements, Case Report Forms (CRFs), CRF Completion Guidelines, Edit Check Specifications, User Acceptance Testing (UAT) plans, and other key documentation.
- Manage data cleaning and validation processes, including discrepancy management, medical coding, and data reconciliation.
- Oversee database lifecycle activities from setup to lock and closeout, ensuring quality and compliance.
- Collaboration and Vendor Oversight:
- Collaborate with cross-functional teams, including Biostatistics, Clinical Operations, and Medical Monitoring, to ensure seamless study execution.
- Manage and coordinate work performed by vendors/CROs, ensuring deliverables meet quality standards and timelines.
- Collaborates cross functionally and with CRO's to ensure SAE/AE reconciliation
- Interacts with clinical sites to ensure timely review and sign off of data for data cuts
- Provide feedback on vendor performance and support vendor selection processes, including RFP reviews and site audits.
- Process Development and Improvement:
- Contribute to the development and continuous improvement of data management processes, including SOP creation and updating.
- Develop and manage KPIs for data quality, process adherence, and productivity.
- Evaluate and implement new tools, systems, and best practices to improve data management efficiency.
- System Testing and Data Review:
- Create and review UAT scripts for EDC and eCOA systems, ensuring quality and completeness.
- Execute UAT to validate system setups, screen configurations, and edit checks.
- Lead internal study team reviews to ensure data quality and compliance with internal and regulatory standards.
- Project and Resource Management:
- Serve as the primary Study Data Manager for assigned clinical trials, ensuring timely and accurate data deliverables.
- Support strategic planning and resource allocation to meet study goals.
- Manage departmental budgets and ensure adequate resources for team development and study execution.
Qualifications
- Education and Experience:
- Bachelor's degree in Life Sciences, Health Informatics, or a related field; advanced degree preferred.
- 7+ years of clinical data management experience in the pharmaceutical or biotechnology industry.
- Technical Skills:
- Proficiency with EDC systems (e.g., Medidata RAVE, Veeva EDC) and clinical data management tools.
- Strong knowledge of ICH-GCP guidelines, CDISC standards (CDASH, SDTM), and FDA regulations.
- Experience with medical coding (MedDRA, WHO Drug) and data transfer specifications for labs, ECGs, and biomarkers.
- Experience with IRT and EDC integrations.
- SAS programming experience is a plus.
- Core Competencies:
- Oncology experience preferred.
- Demonstrated success in managing vendor/CRO relationships.
- Strong organizational, analytical, and project management skills.
- Detail-oriented with a commitment to producing high-quality work.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in a fast-paced environment.
Treeline Biosciences offers a dynamic and innovative work environment with opportunities to contribute to groundbreaking research. Join our team to make a meaningful impact on the development of life-changing therapies.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
- Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
- We do not conduct interviews through Skype or Telegram.
- Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
- You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
- To report job scams, head to ReportFraud.ftc.gov.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.