Manager / Senior Manager, Data Management

Location
92121, San Diego
Posted
Oct 28, 2018
Ref
Position Code: 23123-18U
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

Summary Description

The Senior Manager/Manager Data Management is responsible for the conduct of data management activities outsourced to Clinical Research Organizations (CROs) and in compliance with applicable clinical and regulatory standards. This position will manage the execution of data management activities across multiple programs in phase 1-3 clinical trials in an out-sourced model from study start-up to final clinical study report; identify and anticipate problems and propose risk mitigation plans to ensure successful and timely completion of trials. The role will support the data management team by leading and/or participating in process improvement initiatives, supporting standard data collection development, and mentoring staff as necessary.

Key Responsibilities

•         Provides CRO oversight of the data management functional area and activities; monitor progress and deliverables according to timelines; identify risks and escalate as appropriate

•         Provides oversight and support reconciliation of external data collection (central ECG, lab, biomarkers, etc.) with selected vendors to ensure quality and timely deliverables

•         Review protocol, data management plans, quality plans, eCRFs, and other cross functional documentation to ensure alignment for data collection, review, and consistency

•         Lead sponsor database and data transfer user acceptance testing to ensure quality data

•         Participate in SAE reconciliation with CRO vendor and internal cross functional team

•         Define and identify metrics, expectations, and trends in data that impact data quality, integrity, and timelines

•         Coordinate and lead internal data review on an ongoing basis, during deliverables, and at database lock

•         Coordinate development of standard data reporting with clinical development, clinical operations, biometrics, and other departments to assist with data review, trending, and sponsor oversight

•         Support creation of raw datasets and review specifications for SDTM, and ADAM datasets; Collaborate with larger biometrics team to standardize data receipt from entry to reporting

•         Collaborate across functional groups including Clinical Development, Biostatistics, Clinical Operations, Regulatory, Drug Supply, Project Management, Contracts and Finance to plan and execute responsibilities

•         Assist in defining internal data standards including eCRFs, edit checks, and oversight

•         Participate/lead department and cross-functional initiatives and CRO/external vendor selection

•         Review internal and CRO standard operating procedures, work instructions, and associated documents to ensure documented data management processes are being followed for studies

Experience & Education

 

•                     Bachelor’s degree in a scientific discipline with 8 years’ experience in data management for industry trials

•                     Experience as a lead across multiple trials and programs in various stages of development

•                     Knowledge of EDC systems is required, Medidata Rave knowledge is preferred

•                     Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing conduct of clinical studies

•                     Knowledge and understanding of CDISC standard terminology and familiarity with SDTM

•                     Creative problem solver with the ability to address issues quickly and independently, balanced with judgement to escalate issues as needed

•                     Strong attention to detail and dedication to accurate and high-quality work

•                     Focus on results, highly collaborative cross functionally, positive attitude, and being proactive

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.