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Senior Clinical Trial Manager

Employer
Myovant Sciences
Location
Brisbane, CA
Start date
Sep 21, 2022

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Discipline
Clinical, Clinical Research, Clinical Trials
Required Education
Associate Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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

The Sr. Clinical Trial Manager (Sr. CTM) is accountable for the day-to-day operational oversight of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more Contract Research Organizations (CROs).


Essential Duties and Responsibilities

  • Manages the operational aspects of clinical studies
  • May serve as the Study Management Team (SMT) lead and the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate
  • Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), Project Management Plan, Study Monitoring Plan, Laboratory Manual, Patient Diaries, Clinical Site Procedures Manual, Pharmacy Manual, CRFs/CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities
  • Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)
  • May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Manages oversight of clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • May serve as a line manager to one or more Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs) and/or Clinical Trial Assistants (CTAs)
  • Serves as a leader and mentor to junior team members
  • Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials
  • Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate
  • Serves as a liaison and resource for investigational sites and may have direct interaction with key opinion leaders (KOLs), as needed

Core Competencies

  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • Must have a high degree of professionalism, demonstrates a positive, ‘can do’ and service-oriented attitude and ability to work with limited direction
  • Detail-oriented with a commitment to accuracy
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
  • Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
  • Demonstrate coaching skill to develop team
  • Must have excellent interpersonal, written and verbal communication skills
  • Skilled in developing collaborative internal and external relationships
  • Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

REQUIREMENTS (Education and Experience)

  • At least 8+ years of experience in the pharmaceutical or biotechnology industry
  • BS or BA in a relevant scientific discipline
  • Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Must have strong knowledge of clinical drug development and clinical study processes
  • Extensive experience in managing CROs and other vendors
  • Proven project management skills and study leadership ability
  • Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus
  • 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

Travel

  • Ability to travel up to 15% within North America 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

The well-being and safety of our employees is our top priority.  Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based).  Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.  If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

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.


If you require any accommodations, please email careers@myovant.com.

Equal Employment Opportunity

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Company

We aspire to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. Our experienced team brings significant breadth and depth of expertise in drug development, combined with a commitment to develop new treatments for women suffering from uterine fibroids, endometriosis, and infertility, and men suffering from prostate cancer. We strive to improve the lives of millions of people, while building an innovative, dynamic, and collaborative company where employees thrive.

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Find Us
Website
Phone
650-392-0222
Location
2000 Sierra Point Parkway, Suite 900
Brisbane, CA 94005
United States
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