Senior Clinical Trial Manager

Location
Brisbane, CA, United States
Posted
Jul 08, 2021
Ref
5297648002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

Summary Description

Reporting to an Operations Portfolio Lead (OPL), the Senior Clinical Trial Manager is accountable for independently leading the full scope of assigned global clinical trial(s)/program and leading cross-functional team(s) and Clinical Service Provider (CSP) efforts to ensure clinical trials are executed on time, with quality and within budget. The individual provides leadership within the department and will serve as the Study Management Team (SMT) Lead and line manager to direct reports. Strong leadership, strategic and forward thinking, with the ability to work proactively as an effective team leader in a fast-paced environment are essential for this job. This position is located in our Brisbane, CA office.

Essential Duties & Responsibilities
  • Lead the cross functional SMT and clinical operations team on protocol execution and all operational aspects on one or more clinical trials from start-up through close-out while following SOPs and ensuring compliance with country regulations and ICH/GCP guidelines
  • Serve as primary point of contact and study lead for CRO management, including oversight of operational functional activities (e.g., study management, site monitoring, site management, etc.)
  • Develop and review key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), NDA submission with minimal supervision, as appropriate
  • Lead development of internal and external study documents/plans including, but not limited to, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, pharmacy manual, etc.
  • Develop, manage, and track study timelines against study milestones and communicate timeline risks to all internal and external stakeholders
  • Fiscal and contracts management: oversee and manage overall study budget and contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CSP work order and change order updates
  • People management: manage and support development of direct and indirect reports by mentoring and delegating responsibilities to junior team members, while overseeing and supporting development plans
  • Anticipate complex obstacles and clinical trial challenges and implement solutions to achieve project goals and timelines
  • Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation
  • Develop and present study status and risk mitigations to senior management, as needed
  • Partner with Clinical Business Outsourcing (CBO) on CRO/CSP selection process for outsourced activities including RFP development and review, bid defense meetings, CSP performance and issue resolution
  • Lead and serve as subject matter expert (SME) on various company working groups and participate in the development, review and implementation of departmental SOPs and processes
  • Perform and ensure quality clinical data review and data integrity for assigned clinical trial(s)
  • Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed
  • Partner with Clinical Operations Excellence and Digital Innovation group to implement innovative ideas to improve clinical trial management process and outcomes
  • Organize and present at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings
  • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial

Skills and Competencies
  • Advanced knowledge of clinical research operations, including interpretation and implementation of FDA and other regulatory agency requirements and ICH/GCP guidelines
  • Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials
  • Able to participate in and lead departmental or interdepartmental strategic initiatives under limited supervision
  • Able to examine functional issues from a broader organizational perspective
  • Forward thinking that effectively translates to a clear sense of direction for teams is essential
  • Strong stakeholder management, influencing and negotiation skills
  • Able to lead cross functional teams with strategic agility
  • Direct line management experience in a leadership or team management position
  • Strong project management skills with ability to manage multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment
  • Inspection readiness experience highly desired
  • Demonstrated leadership to drive results that are needed to achieve company goals and objectives
  • Detail-oriented without losing sight of the big picture
  • Required skill in the operation of standard office equipment including: copy machines/scanners and other equipment as necessary
  • Demonstrated proficiency in MS Office (Outlook, Word, PowerPoint and Excel) and Smartsheets

Communication & Interpersonal Skills
  • Excellent interpersonal, communication (verbal and written), analytical and organizational skills
  • Able to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company

Education and Experience
  • At least 8-10 years of clinical trial experience with 2-4 years of direct trial management experience and a BS or BA in a relevant scientific discipline or equivalent
  • Prior experience as a study coordinator or CRA preferred
  • Experience working within a small biotech company preferred

Travel, Physical Demands and Work Environment
  • Willing to travel domestically and internationally
  • Regularly required to operate standard office equipment
  • Ability to work on a computer for extended periods of time
  • Regularly required to sit for long periods of time, and occasionally stand and walk
  • Regularly required to use hands to operate computer and other office equipment
  • Close vision required for computer usage
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity