Olema Oncology
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Director, Clinical Data Management
role at
Olema Oncology .
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 currently in development for metastatic breast cancer. Our follow‑on product candidate, OP‑3136, is a potent KAT6 inhibitor with best‑in‑class potential.
About the Role As the Director of Clinical Data Management reporting to the Sr. Director, Clinical Data Management, you will oversee all data processes for assigned studies, manage data collection workflows across all data sources, ensure the quality and integrity of all clinical data, and lead a team of data management professionals.
Responsibilities
Day‑to‑day management of vendors involved in data management, ensuring quality of deliverables and that timelines are met.
Gather input from stakeholders and design data flow across data sources and vendors.
Develop and review study plans and protocols to ensure that data collection designs meet study objectives.
Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data.
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 during all phases of the project lifecycle, including internal and external audits and inspections.
Lead a team of data management professionals.
Assist in the development and periodic review of Data Management SOPs, work instructions, and templates while assessing metrics and implementing suggested improvements.
Ideal Candidate Profile Knowledge
Bachelor’s degree or higher in science, biology, mathematics or computer science.
CCDM certification preferred.
Experience across early to late‑phase clinical trials; late‑phase oncology experience required.
Practical knowledge of MedDRA, WHODrug or another controlled thesaurus.
Knowledge of Project Management Principles; PMP certification is a plus.
Deep expertise in Excel and MS Office tools.
Relational database understanding and SQL knowledge.
Understanding of data manipulation using SAS, R, or Python/Pandas.
Experience
15+ years in data management within the clinical trial industry (med device, pharma or biotech).
At least 5 years 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 experience with EDC systems (e.g., Rave, Veeva).
Practical experience building studies using CDISC/CDASH standards.
Experience with data visualization tools (e.g., Spotfire, Tableau, RShiny, Dash).
Experience managing data flow and curation of biomarker data a plus.
Experience with a programming language a plus.
Attributes
Excellent verbal and written communication skills.
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines.
A commitment to excellence.
Collegial, hard‑working, confident, self‑starter with a passion for results.
A fast learner who can identify core project challenges and change course expeditiously.
Strong teamwork and collaboration, giving and welcoming feedback.
Demonstrated ability to make decisions in situations with incomplete or ambiguous information.
Professional ethics, integrity and judgment.
Compensation Base salary range:
$205,000 - $220,000
annually. The total compensation package includes equity, bonus, and benefits.
Equal Opportunity 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.
#J-18808-Ljbffr
Director, Clinical Data Management
role at
Olema Oncology .
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 currently in development for metastatic breast cancer. Our follow‑on product candidate, OP‑3136, is a potent KAT6 inhibitor with best‑in‑class potential.
About the Role As the Director of Clinical Data Management reporting to the Sr. Director, Clinical Data Management, you will oversee all data processes for assigned studies, manage data collection workflows across all data sources, ensure the quality and integrity of all clinical data, and lead a team of data management professionals.
Responsibilities
Day‑to‑day management of vendors involved in data management, ensuring quality of deliverables and that timelines are met.
Gather input from stakeholders and design data flow across data sources and vendors.
Develop and review study plans and protocols to ensure that data collection designs meet study objectives.
Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data.
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 during all phases of the project lifecycle, including internal and external audits and inspections.
Lead a team of data management professionals.
Assist in the development and periodic review of Data Management SOPs, work instructions, and templates while assessing metrics and implementing suggested improvements.
Ideal Candidate Profile Knowledge
Bachelor’s degree or higher in science, biology, mathematics or computer science.
CCDM certification preferred.
Experience across early to late‑phase clinical trials; late‑phase oncology experience required.
Practical knowledge of MedDRA, WHODrug or another controlled thesaurus.
Knowledge of Project Management Principles; PMP certification is a plus.
Deep expertise in Excel and MS Office tools.
Relational database understanding and SQL knowledge.
Understanding of data manipulation using SAS, R, or Python/Pandas.
Experience
15+ years in data management within the clinical trial industry (med device, pharma or biotech).
At least 5 years 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 experience with EDC systems (e.g., Rave, Veeva).
Practical experience building studies using CDISC/CDASH standards.
Experience with data visualization tools (e.g., Spotfire, Tableau, RShiny, Dash).
Experience managing data flow and curation of biomarker data a plus.
Experience with a programming language a plus.
Attributes
Excellent verbal and written communication skills.
Analytical thinking with problem‑solving skills and the ability to adapt to changing priorities and deadlines.
A commitment to excellence.
Collegial, hard‑working, confident, self‑starter with a passion for results.
A fast learner who can identify core project challenges and change course expeditiously.
Strong teamwork and collaboration, giving and welcoming feedback.
Demonstrated ability to make decisions in situations with incomplete or ambiguous information.
Professional ethics, integrity and judgment.
Compensation Base salary range:
$205,000 - $220,000
annually. The total compensation package includes equity, bonus, and benefits.
Equal Opportunity 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.
#J-18808-Ljbffr