Senior Manager, Clinical Trial Lead

• Manage all aspects of clinical trials for the given region, 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 including, but limited to, protocol, informed consent,Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documents   
• Triage CRO and clinical site questions   
• Partner with eTMF Team to 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   
• 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  
• Perform and manage data review process in partnership with the Clinical Data Management Team 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  
• Support development and review of Clinical SOPs and other department initiative   
• Other clinical operational duties that may arise

Ideal Candidate Profile >>>

A love of challenging, important work. 

• Bachelor's Degree is required, advanced degree is preferred  
• 8+ years of clinical research experience and 3+ years of clinical trial management (i.e., CTM, CTL, CPM) experience within the biotech or pharma
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management  
• Strong clinical project manager 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 

• Global and phase II/III trial experience is required 
• Oncology experience is required, Breast cancer experience is preferred 
• Experience 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    
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook    
• Proven experience in project management and the use of project management tools for the use in clinical study timelines 
• Experience managing CROs and other clinical vendors  

• Excellent verbal and written communication and skills   
• Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance   
• 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 

Important Information

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