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 develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Clinical Trial Manager. The position reports to the Associate Director, Clinical Operations. The location of the position is in Brisbane, CA.
The Clinical Trial Manager is accountable for the day-to-day operational oversight of one or more clinical trials including trial 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 CROs. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Monitors clinical studies for adherence to protocol, GCP, SOPs, i.e. on site quality monitoring visits, review CRO Monitor trip reports and identify trends
- Ensures quality data generated from sites and assists in resolving subject eligibility, protocol deviation issues and confirms accuracy of clinical data
- Ensures safety issues are reported to safety and follow-up issues to closure within timeframe
- Prepares and maintains study documents (ICF templates, site instructions, work instructions, etc)
- Track and coordinate CRO and vendor activities to ensure scope of work and/or monitoring plans are followed
- Participates in department team or task force to improve processes
- Participates in protocol, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
- Prepares metrics and updates for management, as assigned
- Proactively identifies potential study issues/risks and recommends/implements solutions
- Participates in and facilitates CRO/vendor selection process for outsourced activities
- Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
- May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
- Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Participates in the development, review and implementation of departmental SOPs and processes
- Recommends and implements innovative process ideas to impact clinical trials management
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
- Serves as a liaison and resource for investigational sites
- Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
- Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- 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 excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- At least 5+ years of experience in the pharmaceutical or biotechnology industry and a 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 protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
- Strong experience in management of CROs and other vendors
- Requires proven project management skills and study leadership ability
- Must have excellent interpersonal, written and verbal communication skills
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- 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.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity