Sr. Manager, Clinical Data Management
Sr. Manager, Clinical Data Management
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$ 160000 - 190000
1 Vacancy
Job Description
ABOUT US
Calibr-Skaggs Institute for Innovative Medicines a division of Scripps Research is a first-of-its-kind nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research impacting translational sciences Calibr-Skaggs has created a portfolio of drug candidates and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs drug development portfolio spans a broad range of human diseases including cancer autoimmunity and inflammatory diseases metabolic and cardiovascular diseases infectious and neglected diseases as well as age-related and degenerative diseases. If you have a passion for making a difference this could be your opportunity to join our transformative team.
POSITION TITLE: Sr. Manager Clinical Data Management
POSITION SUMMARY:
The Senior Data Manager will provide leadership and operational oversight for end-to-end data management activities across assigned clinical studies. The incumbent will ensure data are collected processed and delivered to the highest standards of quality integrity and regulatory compliance from study start-up through database lock. This position will provide input into Biometrics strategy and implement department initiatives. This individual will also independently perform/oversee tasks related to database and report setup as well as processing and cleaning clinical trial data.
RESPONSIBILITIE & DUTIES:
- Establish functional strategic initiatives and support development of cross-departmental standard procedures.
- Review protocols from a CDM perspective and provide functional-expert feedback.
- Identify SOPs for Data Management and develop SOPs Working Instructions and templates with cross-functional team.
- Develop and maintain study Data Management Plans (DMPs) eCRF specifications edit-check programming specifications data review and reconciliation plans and data transfer specifications.
- Lead EDCdesign build validation and user acceptance testing; manage mid-study updates and version control.
- Oversee data review query management medical coding (MedDRA WHO Drug) and reconciliation of external data (eCOA/ePRO central labs PK/PD imaging IRT safety/SAE).
- Implement and enforceCDISC/SDTMstandards and controlled terminology.
- Provide day-to-day oversight of CROs and EDC vendors; chair data review meetings; track KPIs and resolve issues.
- Drive interim analyses and final database lock; ensure inspection-ready documentation and timely TMF contributions.
- Ensure compliance with ICH-GCP 21 CFR Part 11 GDPR/HIPAA and internal SOPs.
- Contribute to process improvement CRF libraries edit-check catalogs and data quality dashboards.
- Oversee project plans and timelines for outsourced studies and monitor progress against key milestones.
- Serve as primary data management contact for both internal teams and external vendors.
- Ensure appropriate TMF documentation of data management deliverables.
- Proactively identify and mitigate risks to data quality compliance and delivery timelines.
- Support audit and inspection readiness and participate in CDM process improvements.
- Promote constructive effective relations while collaborating with cross-functional team members such as Clinical Operations Biostatistics Medical Drug Safety and other teams.
POSITION REQUIREMENTS:
- Bachelors degree in Life Sciences Data Science or related field; Masters degree preferred.
- 15 yearsof clinical data management experience in biopharma or CRO including 10 yearsas study lead and/or vendor management oversight lead.
- Proficiency with at least one major EDC platform(e.g. Medidata Rave Veeva CDMS Oracle Inform Medrio).
- Experience with IRT or RTSM and EDC integration.
- Demonstrated experience with CDASH CDISC/SDTM medical coding external data integrations and SAE reconciliation.
- Thorough knowledge of ICH-GCPand 21 CFR Part 11and their application to data systems and processes.
- Familiarity with emerging clinical data technologies such as eSource DCTs and real-time data visualization platforms.
- Strong experience managing CDM activities through CROs or external vendors.
- Familiarity with in-house data management model.
- Experience with eTMF systems and their role in study documentation.
- Excellent technical writing documentation project management and cross-functional communication skills.
- Ability to thrive in a fast-paced resource-conscious and collaborative environment.
PREFERRED QUALIFICAIONS:
- Experience in IBD immunology oncology and/or cell/gene therapystudies.
- Familiarity with ADaMdeliverables and DSMB/IA data packages.
- Working knowledge of SQLor R/Python for listings quality checks and metrics.
- Managerial and oversight experience with junior level data managers.
- Experience in identifying efficiencies and implementing a blended-model of outsourcing specific data management tasks while also overseeing and performing portions of data management tasks in-house.
PHYSICAL REQUIREMENTS:
May include stationary position for an extended period of time traverse campus/facility as needed operate machinery such as computer phone copy machine exposure to cold or hot temperatures.
COMPENSATION:
The expected hiring range for this position is $160000 to $190000 commensurate with experience. Consideration will be given to experience that exceeds the listed requirements.
COMPREHENSIVE BENEFITS INCLUDE:
- Employer Contributed Retirement Plan Depending on eligibility employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
- Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option) dental vision life insurance disability EAP and more
- Access to Flexible Spending Accounts (Medical/Dependent Care)
- Competitive vacation and sick leave policies
- Free on-site parking
The above statements describe the level of work performed and expected in general terms.â The statements are not intended to list all the responsibilities duties and/or skills required of employees so classified and the content herein is subject to change due to the business needs of Scripps Research with or without notice.ââ Furthermore nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.â
EEO Statement:
The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought culture and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability protected veteran status or any other legally protected characteristic or status.
Required Experience:
Manager
Employment Type
Full-Time
