Senior Manager/Assoc Director, Data Management

Summary

Responsible for supporting the planning, oversight and implementation of data collection, cleaning, and locking for clinical trials of multiple studies. Provides support on the development of documents for clinical studies, including protocols, case report forms, data management plans, data transfer plans, standard operating procedures, etc. to ensure consistency within a clinical program and will provide oversight of data management CROs to ensure the quality of all deliverables. May also supervise one or more full-time or contract data managers.

Essential Duties and Responsibilities

• Provide data management support to all clinical studies.
• Manage data management CROs.
• Manage full-time and/or contract data managers.
• Oversee, review and approve all data management documentation.
• Ensure consistency across documentation in similar studies within a program.
• Ensure consistency across data collection activities and eCRF designs within a program.
• Provide technical oversight of contracts supporting clinical trial data activities.
• In collaboration with Quality Assurance, conduct data management vendor qualification audits, as appropriate.
• Assist in the development of a comprehensive approach to coordination, harmonization and oversight of data management activities.
• Proactively anticipate and identify complex issues and problems and make decisions to resolving problems in project planning.
• Oversee the implementation and use of web-based data entry and management platform (ie Medidata Rave) to manage projects
• Provide project management expertise, as needed, to ensure quality and timely completion of project milestones.
• Participate on Clinical Project Teams and Clinical Development Team, as appropriate .

 JOB QUALIFICATIONS

Education, Certifications, Experience

• Bachelor’s Degree or equivalent with minimum of 8 years (Sr. Manager) or 10 years (Associate Director) of experience in leading and supporting data management in clinical research (at various levels and in different capacities), in all phases of clinical research, supporting US as well as international clinical trials.
• At least 2 years’ experience (Sr. Manager) or 4 years’ experience (Associate Director) as a data management lead across multiple trials and programs in various stages of development
• Previous experience hiring, managing, and mentoring direct reports (for Associate Director) is desired but not required.

Knowledge, Skills and Abilities

• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies
• Knowledge of current GCP, ICH (R2/R3), 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
• Ability to analyze information, review reports and prioritize actions.
• Excellent computer skills; strong verbal and written communication skills
• Ability to work well in a team environment both as a leader and a contributor.
• Experience providing training in eCRF used at investigator meetings .
• Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a very fast-paced environment.
• Experience with and/or knowledge of CDISC standard terminology and STDM data format

SPECIAL WORKING CONDITIONS

Must be successful working in a fully remote and/or hybrid work environment / Limited domestic and international travel may be necessary.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

For California based applicants, the expected salary range for this position is $155,000 to $185,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/