Director, Clinical Data Management

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together forour patients, for your career, for what's beyond.You can view our latest corporate deck and other presentations here .About the Role >>> Director of Clinical Data ManagementAs the Director of Clinical Data Management reporting to the Sr. Director, 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 5% travel.Your work willprimarilyencompass:Day-to-day management of vendors involved in data management, to ensure quality of deliverables and that SET timelines are metGather input from stakeholders and design data flow across data sources and across vendorsDevelop 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 trialsEnsure quality of clinical data by review for completeness, accuracy and consistency in accordance with study plansSupport SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical databaseProvide Clinical Data Management subject matter expertise to study team members during all phases of the project life cycle, including internal and external audits and inspectionsLead a team of data management professionalsAssist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvementsIdeal 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 ofknowledge,experience, andattributesfor this role.Knowledge:Bachelor's degree or higher in science, biology, mathematics or computer scienceCCDM certification preferredExperience across early to late-phase clinical trials preferred; late-phase oncology experience requiredPractical knowledge of MedDRA, WHODrug and/or another controlled thesaurusKnowledge of Project Management Principles; a PMP certification is a plusDeep expertise in Excel and MS Office toolsRelational database understanding and SQL knowledgeUnderstanding of data manipulation, for example using SAS, R, or Python/PandasExperience:A minimum of 15+ year experience in data management in clinical trial industry (med device, pharma or biotech)At least 5 years of experience managing data management professionalsIn-depth understanding of clinical and data management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/SDTMIG standardsExperience managing data management CROsDeep experience in reviewing clinical dataHands-on deep experience working with EDC systems (e.g. Rave, Veeva,)Practical experience building studies using CDISC/CDASH standardExperience with data visualization tools (e.g. Spotfire, Tableau, RShiny, Dash)Experience with management of data flow and curation of biomarker data a plusExperience with a programming language a plusAttributes: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 decisionAnalytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlinesA commitment to excellenceCollegial, hard-working, confident, a self-starter and have a passion for resultsA fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organizationStrong 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 othersA demonstrated ability to make decisions in situations where there is incomplete or ambiguous information and where there is a high degree of professional judgment requiredA "difference maker" in terms of one's professionalism and contributionsImpeccable professional ethics, integrity and judgmentThe base pay range for this position is expected to be$205,000 - $220,000annually, 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.Important Information>>>We provideequal opportunity to all employees and applicants for employmentand believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.We offer acompetitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.Fraud Alert:We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in Our official corporate website is ; our careers page is ; our LinkedIn page is . Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.