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/
Vaccination Policy: Gossamer Bio is committed to complying with federal, state and local law on vaccinations. Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing [email protected], because Controller wishes to evaluate your candidacy for employment at Controller.
Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at [email protected].
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
What We Do
Gossamer Bio is a San Diego-based company focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst various targeted patient populations. Founded by the former Receptos executive team, Gossamer Bio’s strategy will be to leverage an asset-rich in-licensing environment, with a focus on areas of high unmet need, utilizing a team with a strong track record of execution in immunology, inflammation, fibrosis and oncology.
