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SR. MANAGER / ASSOCIATE DIRECTOR, DATA MANAGEMENT

Company: Fog pharma
Location: Cambridge
Posted on: June 9, 2024

Job Description:

Why join us?FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.FOG-001, the company's first-in-class TCF-blocking ---catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.What's the opportunity?The Sr. Manager/Associate Director, Clinical Data Management, will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners and collaborating within Biometrics and across cross-functional teams to ensure data deliverables and expectations are met. Responsibilities may include:Provide data management leadership, insight, and support to all internal and external projects and clinical trials.Will function as lead Clinical Data Manger for multiple clinical trials.Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.Manage and provide oversight of data management personnel and activities of CROs and vendors.Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.Engage in cross-functional meetings, providing updates on project status, issues, and milestones.Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.Lead interactions with third party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.Contribute to SOP development and updates to meet regulatory compliance and operational needs.What you'll need to be successful:Bachelor's degree in Life Science, mathematics, or health-related fields preferred.Minimum of 8-10 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.Experience in the Oncology therapeutic area is preferred.Proven ability to manage CRO relationships and oversee data management deliverables.Strong knowledge and experience of EDC systems (Veeva and Medidata RAVE preferred).Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.Excellent verbal and written communication skills.Strong analytical and problem-solving abilities.Core ValuesFogPharma is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.Creative. We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.Humble. We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.30 Acorn Park Drive - - - - - -Cambridge, MA 02140 - - - - - www.fogpharma.com

Keywords: Fog pharma, Cambridge , SR. MANAGER / ASSOCIATE DIRECTOR, DATA MANAGEMENT, Executive , Cambridge, Massachusetts

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