Senior Director, Clinical Data Management

About the Role >>> Senior Director, Clinical Data Management 

As the Senior Director of Clinical Data Management reporting to the VP, Clinical Operations, you will be responsible for all clinical data management activities for Olema’s clinical studies. This high-impact role involves building and scaling the department, defining strategy, and establishing an efficient operating model. You will be accountable for creating and maintaining data processes and standards, ensuring the seamless integration and quality of data from electronic data capture (EDC) systems and non-EDC sources. In addition, you will be responsible for creating the data reporting reports through metrics, analytics, and dashboard, building the standards for data collection, edit specifications, Data Management Plans, data systems validation and UAT, listing generations, as well as review of clinical data for completeness, accuracy, and compliance 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 20% travel. 

Your work will primarily encompass: 

• Lead and recruit a team of data management professionals to ensure data collection, cleaning, and integrity are performed with quality and efficiency. 
• Oversee vendors involved in clinical data management including electronic data capture (EDC), electronic patient reported outcomes (EPRO), interactive response technology (IRT), and data visualization to ensure quality of deliverables and that set timelines are met. 
• Develop and review study plans and protocols to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines). 
• Create the standards for development and review specifications for CRFs, database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for Olema clinical trials. 
• Accountable for deliverables to meet departmental and appropriate company goals.   
• Prepare for audits and regulatory inspections by ensuring data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans. 
• Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections. 
• Manage development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements. 
• Generate metrics, reports, dashboards, and analytics to measure the performance of Clinical Data Management team across the portfolio. 
• Represent clinical data management as Subject Matter Expert (SME) at Clinical Department Meetings and in building relationships with key vendors, providing outsourcing solutions, creating request for proposals (RFPs), reviewing and commenting on vendor proposals, and representing the team at Joint Operating Committee (JOCs). 
• Effective interaction with senior level management across multiple functions. 

Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• BS/BA degree or higher in science, biology, mathematics or computer science. 
• CCDM certification preferred. 
• Practical knowledge of MedDRA, WHODrug and/or another controlled Thesaurus. 
• Knowledge of Project Management Principles; a PMP certification is a plus. 
• Deep expertise in Excel and office tools. 
• Relational database understanding and SQL knowledge. 
• Understanding of data manipulation, using SAS, R, or Python/Pandas. 

Experience: 

• 15+ years of experience in data management in Clinical Trial industry (med device, pharma or biotech). 
• 10+ years of experience managing data management professionals. 
• In-depth understanding of Clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/ standards. 
• Oncology and Clinical Trial Phase 3 experience is a must. 
• Experience managing Data Management CRO’s. 
• Deep Experience in reviewing clinical data. 
• Expertise in data standardization. 
• Hands-on deep experience working with EDC systems (e.g. Rave, Medrio, Inform). 
• Practical experience building studies using CDISC/CDASH standard. 
• Experience with Data Visualization Tools (e.g. Spotfire, Tableau, RShiny, Dash). 
• Experience with management of data flow and curation of biomarker data a plus. 
• Experience with a programming language is a plus. 

Attributes: 

• 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. 
• Be collegial, hard-working, confident, a self-starter and have a passion for results.  
• Be a fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization. 
• 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. 
• Be a “difference maker” in terms of one’s professionalism and contributions. 
• Have impeccable professional ethics, integrity and judgment. 

The base pay range for this position is expected to be $253,000 - $267,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

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