Senior Manager of Clinical Data Management – Job #1013
We are looking for an individual to oversee the day to day Clinical Data Management (CDM) support for a dynamic and fast-growing company. This includes the EDC build and UAT, study data cleaning and reconciliation, query generation and resolution, database snapshots, and database locks. This position reports to the Vice President of Clinical Operations or designee and will be based either in Redwood City, California or remotely in the United States.
Responsibilities:
- Oversee all clinical data management activities and lead strategic initiatives for the function.
- Define requirements for collection forms for new study protocols to ensure all data required for study endpoints are collected. Perform user acceptance testing of prototype EDC and review eCRF flow dynamics and data edit specifications created by EDC vendor. Review and approve data transfer plan for any external data that are imported into EDC (e.g. central lab data). Approve final EDC for all clinical trials. Monitor data collection in newly launched studies for any problems with eCRFs and work with EDC vendor to resolve any issues.
- Direct data review activities for all studies on an ongoing basis. Identify issues to check for when reviewing clinical data, direct internal and external data reviewers, and serve as a working data manager.
- Coordinate activities to lock clinical databases. Develop timelines for data cleaning, identify data review tasks, and assign and coordinate data review activities to internal and external resources. Provides programmer with requirements for data listings. Monitor the progress of source document verification and data query resolution, and alert the Clinical Project Manager of any potential problems. Maintain log of any data issues that may impact analysis of data. Approve final database lock documentation for all clinical trials.
- Plan, manage and coordinate all global data management activities to ensure consistency of clinical data standards across programs
- Manage and lead the design and implementation of CDM processes with vendors, including overseeing vendors responsible for creating EDC systems and transferring external data into EDC.
- Approve Data Management Plans, Data Transfer Agreements, Data Edit Specifications, any changes to EDC.
- Generate ad hoc requests for data listings from Allakos management.
- Works collaboratively with clinical project managers, programmers, clinical research associates, and others to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
Qualifications & Expertise
- Bachelor's degree or higher with 7+ years of hands-on CDM experience in the pharmaceutical/biotechnology industry.
- Proven experience in locking multiple study databases.
- Expert knowledge of data management collection tools and experience with EOC, and related COM systems.
- Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.
- Proven ability to preemptively identify data and system issues, and mitigate risks to data quality.
- Knowledge of COM regulations.
- Excellent interpersonal communication skills.
- Work independently and with small teams in a fast-paced, non-traditional work environment in a start-up, clinical stage biotechnology company.
- Willingness to work non-traditional hours during the period leading to database lock or other data deadlines. Take ownership of all COM activities as needed, with particular attention to study requirements around EOC deployment, maintenance and database lock.
- Effectively interact with individuals who are on site, remotely based in the United States, and in other countries.
- Proficiency in Excel.
The salary is competitive and commensurate with experience and qualifications
Interested applicants, please send resume to Clinicalcareers@allakos.com and reference job #1013
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.