Director / Associate Director / Senior Manager, Data Management - San Diego, CA | Biospace
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Director / Associate Director / Senior Manager, Data Management

Fate Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
166JK
Salary:
Required Education:
Other
Areas of Expertise Desired:
Oncology, Programmer,

Job Description

Fate’s Biometrics team is currently seeking a skilled and motivated data management professional to contribute to and manage the database development and ongoing quality of the data for the Company’s clinical trials.  This is a full-time position reporting to the Vice President, Biometrics and is located at our corporate headquarters in San Diego, CA.

Responsibilities:
•   Provide data management expertise related to CRF design, database build, and data cleaning for multiple clinical development programs to ensure clinical data of the highest quality
•   Manage data management deliverables in coordination with internal stakeholders and external vendors
•   Provide oversight to external data management vendors and manage data transfers to/from such vendors
•   Coordinate cross-functional input into optimal database design
•   Work closely with medical, clinical operations and biostatistics colleagues on the resolution of issues with clinical data
•   Author and review applicable sections of data management related documents such as case report forms, data management plans, data transfer specifications, coding standards, manual review plans, line listing review plans, data validation plans, and clinical study reports and any other related documents
•   Assist in the development of innovative and robust methods for ongoing data review as well as pharmacovigilance monitoring
•   Oversee the development of and implement data management standards for the department
•   Provide data review listings and other tools on an ongoing basis to assist in internal data review
•   Management and mentorship of junior members of staff
•   Contributions to other tasks as required

Requirements

•   10+ years of direct data management experience in drug/device development, or equivalent experience
•   Track record of professional development with increasing levels of responsibility in the design and analysis of clinical trial data
•   Strong knowledge of GCP, ICH, CDASH, CDISC and other pertinent regulatory guidance
•   Willingness to develop/learn innovative data management methodology
•   Experience in managing junior members of staff
•   Excellent communication skills
•   Strong team player
•   Ability to manage multiple competing priorities
•   Oncology clinical trial experience strongly preferred

Working Conditions and Physical Requirements
•   100% on-site work at corporate headquarters in San Diego, CA
•   Occasional evening and weekend work will be required
•   Ability to travel domestically and internationally up to 20% of the time


The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

For consideration send cover letter and resume to:  careers@fatetherapeutics.com and reference job code 166JK.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company's hematopoietic cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf product candidates derived from engineered induced pluripotent cell lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company's novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.