Who We Are >>> Why You Should Work With Us
Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.
Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.
About the Role >>> Director of Clinical Data Management
As the Director of Clinical Data Management reporting to the Vice President, Clinical Development Operations, you will be responsible for all data processes related to assigned studies, overseeing data collection workflows across the EDC database and non-EDC data sources. Ensures the quality and integrity of all clinical data via CRF and 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 is a fantastic opportunity for a hands-on experienced clinical data manager to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.
This role will be based out of our San Francisco, CA or Cambridge, MA office.
Your work will primarily encompass:
- Lead a team of data management professionals
- Day-to-day management of vendors involved in data production and manipulation, to ensure quality of deliverables and that set timelines are met
- Develop and review study plans and protocols to ensure that data collection and 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)
- Develop and review specifications for 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
- Ensure data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans
- Gather input from stakeholders and design data flow across EDC and non-EDC data sources and across vendors
- Manage and oversee SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database
- 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
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.
- Sc./B.A. 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, for example using SAS, R, or Python/Pandas
- 10+ year experience in data management in clinical trial industry (med device, pharma or biotech)
- At least 3 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/SDTMIG standards
- Experience managing Data Management CROs
- Deep Experience in reviewing clinical data
- Hands-on deep experience working with EDC systems (e.g. Rave, Medrio, Inform)
- Practical experience building studies using CDISC/CDASH standard
- Familiarity 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 a plus
- 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
Important Information >>>
We provide equal opportunity to all employees and applicants for employment and 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 a competitive 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.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.