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Associate Director/Director, Data Management

3 months ago

Remote, Oregon, United States Cogent Biosciences Full time

Who We Are

Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent's lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

Our Team

The Associate Director/Director will be accountable for managing day-to-day operations of data management activities. The candidate will be responsible for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews.

This role partners with key study/program team members to develop and implement project plans for assigned studies, ensuring the functional activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial. Develops study level quality and oversight plans, ensures adherence and consistent execution across the data flow. Accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.

Responsibilities

  • Accountable for data management activities for Cogent Biosciences clinical studies, coordinating tasks and deliverables across multiple programs
  • Oversee CRO data management activities that support ongoing clinical programs
  • Lead Data Management in cross-functional Study Team Meetings
  • Oversee project level data management strategy and manage DM project budgets.
  • Provides input to improve data processes and organization in alignment with other development functions.
  • Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • Leads the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
  • Manage / assign responsibilities for Data Managers and act as primary Data Management contact and contributor for projects
  • Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
  • Ensures that Data Management Plans, SOPs and applicable established guidelines of national and international regulatory authorities are followed throughout the course of the studies.
  • Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Oversee the User Acceptance Testing (UAT) of EDC databases by CRO and internal teams. Coordinate UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Ensure clinical data within EDC is of high quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
  • Accountable for eDiary, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
  • Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
  • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
  • Coordinate and communicate with DB vendors on consistent basis to address Clinical team's requests, project plans, and/or eCRF development activities.
  • Participates in the preparation and presentation of data, when applicable.
  • Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits.

Qualifications

  • Bachelor's degree or higher in a scientific discipline
  • Minimum of 7 years of clinical data management experience in pharma/biotech
  • Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company
  • Experience working in an outsourced data management model
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
  • Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management
  • Prior experience filing an NDA preferred
  • Ability to manage multiple initiatives and shifting priorities within a small company environment
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment

Our Locations

Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent's discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.