9 Senior Manager, Data Management Jobs in Santa Monica, CA
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Senior Manager, Data Management
$131k-174k (estimate)
Full Time | Scientific Services
7 Days Ago
Biospace is Hiring a Senior Manager, Data Management Near Santa Monica, CA
At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position SummaryThe Senior Manager of Data Management will be responsible for performing/overseeing outsourced Data Management activities that support Neogene clinical trials worldwide. You will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Manager should have a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Location: Available in Gaithersburg, MD, New York City, NY, Waltham, MA, or South San Francisco, CA.
Responsibilities
The annual base salary for this position ranges from $145,000 to $171,000 However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Benefits
Position SummaryThe Senior Manager of Data Management will be responsible for performing/overseeing outsourced Data Management activities that support Neogene clinical trials worldwide. You will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Manager should have a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Location: Available in Gaithersburg, MD, New York City, NY, Waltham, MA, or South San Francisco, CA.
Responsibilities
- Manage and monitor the progress of data management activities with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
- Represent Data Management during internal Neogene calls or meetings.
- Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs).
- Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors in designing eCRFs, creating the annotated eCRF, and CRF completion guidelines.
- Oversee and participate in the development of data edit check specifications and data listings.
- Coordinate the testing of Electronic Data Capture (EDC) systems according to company standards.
- Oversee and participate in the development of the Data Management Plan for a clinical study.
- Able to review and provide feedback to the clinical team on other study documents e.g. safety reconciliation plan and third party data transfer specs.
- May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
- Oversee reconciliation of third party data from external data sources against the clinical database
- Oversee Serious Adverse Event reconciliation activities according to SOPs and guidelines.
- Oversee and participate in database upgrades/migrations including performing User Acceptance Testing, as required.
- Oversee, with the Clinical Operation, maintenance of data management files.
- Coordinate Data Review and conduct Data Review meetings with cross functional study team members to ensure on-going review of study data currency, quality and completeness.
- Oversee and participate in the database lock and freeze activities per SOPs and timelines.
- Participate in regular team meetings and provide input when appropriate.
- Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
- Assist with the training of new employees and/or contractors, or CROs.
- Ability to run standard and Ad-hoc reports from clinical study databases as needed by study teams or medical monitors.
- Other duties as assigned.
- May manage in-house or contract data management staff as needed.
- 8 years in Pharmaceutical and/or CRO setting with BS/BA in the scientific/healthcare field.; 6 years with MS/MA or MBA; 3 years with PhD
- 5 years of management experience
- Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, including study lead experience.
- Have good project management skills and a proven ability to multitask.
- Understand the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
- Possess a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
- Knowledge of submission requirements preferred (e.g. NDA, BLA and MAA)
- Experience working with CDISC (SDTM) in data collection preferred.
- Experience in oncology/hematology drug development is preferred.
- Extensive experience in managing and collaborating with CROs.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possess solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems.
- Excellent verbal and written communication and presentation skills.
- Able to travel to off-site meetings or training seminars as needed.
- May require occasional evening and/or weekend commitment.
The annual base salary for this position ranges from $145,000 to $171,000 However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Benefits
- Short-term incentive bonus opportunity
- Equity-based long-term incentive program
- 401(k) plan
- Paid vacation and holidays; paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$131k-174k (estimate)
POST DATE
06/22/2024
EXPIRATION DATE
07/08/2024
WEBSITE
biospace.com
HEADQUARTERS
CERRITOS, CA
SIZE
50 - 100
FOUNDED
1985
CEO
KI CHUL CHA
REVENUE
$10M - $50M
INDUSTRY
Scientific Services
Related Companies
About Biospace
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The following is the career advancement route for Senior Manager, Data Management positions, which can be used as a reference in future career path planning. As a Senior Manager, Data Management, it can be promoted into senior positions as a Data Management Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Manager, Data Management. You can explore the career advancement for a Senior Manager, Data Management below and select your interested title to get hiring information.
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