Senior Manager, Clinical Data Management

Olema Oncology•San Francisco, CA

3d•$180,000 - $200,000•Hybrid

About The Position

As the Senior Manager, Clinical Data Management reporting to the Senior Director of Clinical Data Management, you will be responsible for all data processes related to assigned studies, overseeing data collection workflows across all data sources, ensuring the quality and integrity of all clinical data including CRF and edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, as well as ensuring review of clinical data for completeness, accuracy, and compliance. This role is based out of either our San Francisco CA or Cambridge MA office and will require approximately 5 –10 % travel.

Requirements

Bachelor’s degree or advanced degree in a relevant discipline is required
CCDM certification preferred
Practical knowledge of MedDRA, WHODrug and/or another controlled medical dictionaries
Knowledge of Project Management Principles
Deep expertise in Excel and Microsoft Office tools
Relational database understanding and SQL knowledge
Data Visualization Tools experience preferred
A minimum of 8+ years of experience in data management in clinical trial industry (pharma or biotech)
In-depth understanding of clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/SDTMIG standards
Extensive experience managing Data Management CROs
Deep experience in reviewing clinical data
Hands-on deep experience working with EDC systems (e.g. Rave, etc.), IRT systems, and ePRO systems
Practical experience building studies using CDISC/CDASH standard
Experience with data visualization tools (e.g. Spotfire, Tableau, RShiny, Dash)
Excellent verbal and written communication and skills, coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision
Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
A commitment to excellence
Collegial, hard-working, confident, a self-starter and have a passion for results
A fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
Strong teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
A demonstrated ability to make decisions in situations where there is incomplete or ambiguous information and where there is a high degree of professional judgment required
Impeccable professional ethics, integrity and judgment

Nice To Haves

Experience with management of data flow and curation of biomarker data a plus
Experience with a programming language a plus

Responsibilities

Day-to-day management of vendors involved in data management to ensure quality of deliverables and that study timelines are met
Gather input from stakeholders and design data flow across data sources and across vendors
Develop and review study plans and protocols to ensure that data collection designs meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines)
Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data while enabling near-real time data access for Olema clinical trials
Ensure quality of clinical data by review for completeness, accuracy and consistency in accordance with study plans
Support SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database
Provide Clinical Data Management subject matter expertise to study team members during all phases of the project life cycle, including internal and external audits and inspections
Assist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements