Clinical Data Manager - San Diego, CA | Biospace
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Clinical Data Manager

MEI Pharma, Inc.

Location:
San Diego, CA
Posted Date:
9/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description


MEI Pharma (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective oral PI3K delta inhibitor, and ME-344, a novel mitochondrial inhibitor.   MEI currently has an open position for:

Clinical Data Manager

Job Summary:

MEI Pharma, Inc. is seeking a highly motivated professional to provide technical and operational support for data management activities for global clinical trials. Reporting to the Senior Manager, Data Management, this person will be an integral member of the Clinical Operations team whose work enables the Company to meet defined goals for the various clinical development programs.  They will be responsible for the execution and of data management activities, in conjunction with CROs and other Data Management team members – utilizing best practices to ensure budgets, timelines and performance requirements are met.

Essential Duties and Responsibilities:

•   Work independently and collaboratively (with internal or CRO team members) across all Data Management activities
•   Participate in cross-functional team meetings and communicate with appropriate departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CROs.
•   Develop and review Database Specifications and documentation (e.g. Data Management Plans, CRF layouts, Edit Check Specifications, CRF Completion Guidelines, Data Review Guidelines).
•   Participate in User Acceptance Testing.
•   Participate in the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.
•   Develop and Test Data Transfer Specification in conjunction with all applicable vendors participating in a clinical study, performing data reconciliation periodically on the data being transferred.
•   Review medical coding and up-version as needed (WHO Drug/MedDRA)
•   Develop and validate Clinical Data Reports (e.g. Overall Survival, Response Duration, Clinical Data Listings) and Metrics (e.g. enrollment status, query status, data review levels)
•   Conduct exports of data from EDC systems for Medical Monitor review
•   Develop, maintain, and review appropriate data management SOPs (associated with the data collection, handling and review processes to meet regulatory compliance and operational needs).
•   Participate in QC of Clinical documents (e.g. Clinical Study Reports, Manuscripts)
•   Work independently, exercise appropriate judgment and utilize effective communication.
•   Serve as a technical resource to colleagues; troubleshoot technical problems.
•   Assist in the compilation of clinical data for regulatory submissions.
•   Other tasks as may be necessary to support Data Management goals at MEI Pharma, Inc.

Requirements



Education and Competency Requirements:
•   Bachelor degree in a scientific, IT, or related field of study
•   Oncology therapeutic area experience preferred
•   Minimum of 3 years data management experience in pharmaceutical/biotech/CRO industry
•   In depth knowledge with all aspects of data collection and query resolution in clinical studies
•   Strong working knowledge of GCP, CDISC data structures (CDASH, SDTM, ADaM), 21 CFR Part 11, ICH guidelines and FDA regulations
•   Knowledge of EDC, CTMS, IXRS, and ePRO software
•   Proficiency with SQL, spreadsheet data manipulation, and standard reporting tools
•   Ability to prioritize competing priorities across different projects within timeline and budget constraints
•   Analytical mind with strong attention to detail
•   Demonstrated capabilities and proven track record of problem solving skills
•   Excellent communication skills (oral and written) and interpersonal skills
•   Ability and willingness to travel up to 10% of time, including domestic and international travel
•   Highly motivated team player willing to work and collaborate cross-functionally.

ADA Notations:

•   Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
•   Regular communication (hearing/speaking).
•   Lifting up to 25 lbs.
•   Routine office duties including computer keyboard use
•   Vision requirements include: close vision and ability to focus.
•   Noise conditions range from quiet to moderate.