Clinical Trial Manager

Olema Oncology (NASDAQ: 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), is in development to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema recently initiated a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250. We are supported in our mission by experienced and accomplished scientists and board members, leading healthcare investors, and some of the most innovative pharma companies. For more information about the company please visit www.olema.com

The Role:   We are looking for a Clinical Trial Manager (CTM) for our growing Clinical Operations team. The Clinical Trial Manager is responsible for the day to day management of clinical trials, vendors, and clinical trial sites. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines, and budgets. We are looking for a capable trial manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.

This is a fantastic opportunity for a hands-on Clinical Trial 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 position is available in either our San Francisco or Boston office.

What You Will Do:

• Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial  
• Support cross-functional study execution team in support of study deliverables with focus on Clinical Operations deliverables to the study team 
• Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership 
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs  
• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents  
• Triage CRO and clinical site questions  
• Facilitate cross-functional study team meetings and/or can delegate to a Sr./CRA, as appropriate; liaise with other cross-functional areas for oversight of clinical study activities.  Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews  
• Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files  
• Responsible for and participates in service provider selection process as a part of outsourcing activities 
• Proactively identify and resolve clinical project issues and participates in process improvement initiatives as required  
• Responsible for assessing operational feasibility, recommending study execution plan and site selection  
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers.  
• In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents  
• Support oversight of clinical trial budgets, providing ongoing financial reporting and projections 
• Negotiate and finalize site contracts and budgets 
• Perform and manage data review process on an ongoing basis 
• Oversight of site visits including site qualification, initiation, monitoring and close-out visits, as needed 
• Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues  
• Ensure tracking and review of protocol deviations and assesses impact on study data  
• Review and approve clinical invoices for vendors  
• Provide oversight for forecasting of clinical supplies, including study drug and supplies 
• Oversee work of junior Clinical Operations staff  
• Support development and review of Clinical SOPs and other department initiative  
• Travel as needed to sites, conferences, industry meetings  
• Other duties as may be assigned 

What You Will Bring:

• Bachelor's Degree is required 
• 7+ years of clinical research experience within the Biotech or similar industry  
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management 
• Strong clinical study management skills 
• Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met  
• Excellent communication skills to effectively disseminate information to project team and outside parties  
• Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management 
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology  
• Excellent organizational, conflict resolution, prioritization and negotiation skills  
• Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance  
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook  
• Working knowledge of MS Project for development and update of clinical study timelines
• Available to travel 15% of the time

Personal Characteristics:  

Given the “small biotech” nature of the Company, cultural fit of the successful candidate is an important criterion for their success at Olema. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow through are essential for this job.   Specific personal characteristics include: 

• Excellent verbal and written communication and skills.  
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines.  
• A commitment to excellence. 
• 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. 
• Entrepreneurial mindset and the ability to prioritize key work streams and requirements that will change over the near and mid-term. 
• A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required. 
• Be a “difference maker” in terms of one’s professionalism and contributions. 
• Have impeccable professional ethics, integrity and judgment. 
• Be collegial, hard-working, confident, a self-starter and have a passion for results.   

Additional Information:   We require all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations.   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.    Olema offers competitive compensation and benefits. We seek 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.   Please note: Olema does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.