Senior Manager, Data Management
- Olema Oncology
- San Francisco, California
- Start date
- Mar 10, 2023
- Clinical, Clinical Data, Information Technology, Business/Data Analytics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
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 >>> Senior Manager, Data Management
As the Senior Manager, Data Management reporting to the Director of Clinical Data Management, you are responsible for all data processes related to assigned studies, overseeing data collection workflows across the EDC database and non-EDC data sources. Additionally, the Data Manager will ensure the quality and integrity of all clinical data via CRF and edit check specifications, Data Management plans, data systems UAT, listing generations, vendor data reconciliation as well as review of clinical data for completeness, accuracy, and compliance.
This role is based out of either our San Francisco or Cambridge office and will require around 15% travel.
Your work will primarily encompass:
- Overseeing CRO Data Management
- Assist in study start-up activities (CRF design, UAT, edit checks review, etc.) and ongoing data management activities (e.g. reconciliations, data cleaning initiatives)
- Review protocols to ensure the data collection, database and reporting requirements can be met
- Perform data trend analysis and oversee data cleaning and database lock activities
- Assist in review of data management related documents prior to approval (data management plan, CRF Completion Guidelines, edit check specifications, coding guidelines, SAE reconciliation plan, vendor data transfer agreements, etc.)
- Review CRF metrics reports against project data deliverables
- Act as the primary data management lead across projects within the cross functional team and CRO data management
And will also include:
- Participate in internal team meetings and provide data management updates on assigned studies
- Provide vendor oversight, as necessary. Acts as primary liaison with third party data vendors, EDC vendors
- Interface with Clinical, Biostatistics, Clinical Scientist and Project Management to troubleshoot data-related problems
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.
- BS/BA degree preferably in a health related or life sciences field
- Proficiency with electronic data collection systems (e.g., RAVE, Medrio, IRT systems)
- Minimum of 8 years of clinical data management experience in the pharmaceutical, biotechnology industry working with clinical trial data
- Oncology experience preferred
- Experience working with MS Office suite (Excel, Word, PowerPoint)
- Excellent verbal and written communication within a cross functional team
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Self-motivated and enthusiastic; 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
- Strong skills in attention to detail and flexibility
The base pay range for this position is expected to be $165,000 - $180,000 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.
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.
We exist to develop therapies that offer the potential to improve outcomes for women living with cancer. We approach these goals with a single-minded focus.
At Olema Oncology, we leverage our deep understanding of endocrine-driven cancers, nuclear receptors and mechanisms of acquired resistance with the goal of transforming the standard of care for women living with cancer by focusing on developing more convenient and effective therapies. Join us as we aim to design therapies for improving lives.
Why Join Us?
We 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 provide equal opportunity to all employees and applicants for employment and offer competitive compensation and benefits.
Olema seeks to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers.
Located in Cambridge, MA and San Francisco, CA
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