About the Role >>> Senior Manager, Clinical Trial Leader

We are looking for a Senior Manager, Clinical Trial Leader (CTL) for our growing Clinical Operations team. The Senior Manager, Clinical Trial Leader 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 Lead 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.

Your work will primarily encompass:

• 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 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
• 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
• Manage / 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

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.

Knowledge:

• Bachelor's Degree is required, advanced degree is preferred
• 8+ years of clinical research experience and 3+ years of clinical trial management experience within the biotech or similar industry
• 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

Experience:

• Global and Phase III trial experience is required
• Oncology experience is required, Breast cancer experience is preferred
• 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
• Experience managing CROs and other clinical vendors

Attributes:

• 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
• Available to travel 15% of the time

The base pay range for this position is expected to be $170,000 – $190,000 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.

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