Carmot Therapeutics , Inc.
Location
Berkeley, CA | United States
Job description
Carmot Therapeutics, Inc. is a clinical stage biotechnology company dedicated to delivering life-changing therapeutics for people with metabolic diseases. To support this vision, we are looking for an experienced and highly motivated Associate Director to lead the data management activities for all Carmot clinical programs in all phases of clinical development. The Associate Director will be a key member of a highly collaborative Clinical Development team. This position reports to the Head of Data Management, Biostatistics and Statistical Programming. The level of the position will be commensurate with the candidate's education and industry experience.
Responsibilities
Demonstrate subject matter expertise in all aspects of the CDM discipline, driving the team's strategy, capabilities, systems, and deliverables.
In collaboration with key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements. Optimize data management and collection activities for cross-trial consistency and identifying standard case report form modules.
Collaborate cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
Build and lead a high-performing CDM team including full time employees, contractors, and third-party vendors.
Develop policies to manage CROs, EDC developers, and other external data management vendors. Oversee external data management vendors in respect to key performance indicators, metrics, program level deliverables, timelines, and budgets; participate in vendor selection activities. Make expert recommendations and/or decisions that assure timelines and deliverables.
Develop and maintain departmental policies in accordance with regulatory requirements.
Support regulatory submissions including FDA audit readiness, presentation, and response.
May support the creation of SDTM datasets, which may include oversight of external vendors.
Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations.
Propose, draft, and maintain relevant Standard Operating Procedures and other policies and procedures relevant to the department; participate in systems selection and implementation activities.
Contribute to infrastructure requirements for interactive data visualization and analytic tools for reporting and data QC.
Education and Experience
Bachelor's degree in a science related field is required.
Minimum 8 years of direct data management experience and a minimum of 2 years' experience in a supervisory role.
In depth knowledge of clinical data management in Biotech, Pharmaceutical or CRO industry.
Entrepreneurial drive and operational excellence savviness.
Strong project management skills and experience working with CROs/vendors.
Strong experience in data management-related activities, with thorough understanding of clinical trials process and regulatory requirements, including CDISC requirement, specifically SDTM Mapping.
Strong experience in design and validating EDC databases and performing data review; familiar with safety laboratory data management and dictionary coding for adverse events and medications.
Ability to be hands-on with database cleaning, generate patient level listings as needed.
Proven ability to collaborate in high performing teams, excellent conflict resolution skills.
Be science and data driven while at the same time, be creative and flexible in strategic thinking and problem solving.
Demonstrated leadership quality and superior organizational and interpersonal skills.
Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting.
Highly experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance.
Knowledge of GCP, ICH and other regional regulations and compliance.
Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving.
Competence in Excel and/or SAS programming is a big plus.
Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS).
EDC building skills is preferred.
Carmot offers competitive compensation, and a comprehensive health & wellness package that includes the following:
Choice of medical insurance plans which includes PPOs and HMOs
Dental and vision insurance
Life, short- and long-term disability
401(k) Retirement Plan with Company Contribution
Separate paid vacation and sick time plans
Wellness Days
Maven Clinic, which offers support and family-forming benefits for employees on any path to parenthood, plus pediatrics, menopause support, and more
Spring Health, a full service mental health platform that pinpoints and delivers the right level of care for each employee and their dependents, including digital support, meditation, coaching, therapy, medication and beyond
Must be authorized to work for any employer in the U.S.
Carmot Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.
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