- Support Study Lead and take on responsibility and management of clinical trial to ensure that corporate goals are met, studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
- Responsible for study start-up, including working with cross functional teams on startup, and with the CRO on site selection/activation.
- Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures.
- Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense for CRO and finalization of SOW), imaging, central and specialty labs, eCOA, and compliance.
- Manage vendor operational meetings to ensure project goals and timelines are met.
- Assist with or be responsible for the management of key study parameters (e.g., start-up activities, site feasibility, enrollment, site management, data collection, data review, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
- Participate in the development and review of study related materials, including but not limited to informed consent forms, case report forms, study manuals and plans, and other supporting clinical trial materials.
- Create study specific tools and manuals to ensure timeliness, standardization, and control of data quality.
- Assist with the analysis and development of action plans to address issues with investigational sites and/or vendors.
- Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials.
- Review/approve invoices, and ensure timely payment processing for vendors, including investigative sites (as applicable).
- Ensure inspection-readiness for all assigned studies, including ensuring all components of the trial master file (TMF/eTMF) are up to date and accurate.
- Assist with the planning, coordination, and presentation at Investigator Meetings and CRA Training meetings, SIVs, and ad hoc trainings, as requested.
- BA required, preferable in a scientific/medical field. Advanced degree preferred.
- 7-10 years of experience in Clinical Operations or related function, working with CROs and other vendors, with increasing responsibility and scope; Oncology experience preferred.
- Early phase and start up experience required.
- Working knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
- Previous experience working in cross-functional environment.
- Demonstrated experience in selecting, managing, overseeing, and successfully developing effective relationships with multiple vendors and CROs.
- Proficiency with Microsoft applications
- Prior experience working in a start-up environment is a highly desired.
- Highly motivated and enjoys working in a fast-paced, dynamic environment.
- Strong organizational skills and ability to prioritize and multi-task.
- Possess strategic thinking and proactive identification and potential solutions of issues.
- Positive, flexible, self-starter, and thrives under pressure.
- Excellent judgment and problem-solving skills.
- Exceptional verbal and written communication skills.
- Flexible related to responsibilities/assignments as Biomea Fusion is a small company and job scope/role may evolve as the company grows and matures.
- Willingness to travel as necessary, consistent with project needs
- Ability to work cross-functionally at all levels within Biomea Fusion and externally with consultants/contractors, vendors, investigators, and study site personnel.
- Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activates.
- Biotechnology
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Contract Clinical Trial Manager-Sr. Clinical Trial Manager - Redwood City, United States - Biomea Fusion Inc.
Description
Position Summary:
This is an exciting opportunity to work within a fast-paced environment with a dedicated, passionate, intelligent team.
As a Contract Clinical Trial Manager, you will be responsible and accountable for managing operational activities for assigned studies and may assume responsibility for additional vendors, studies and/or clinical programs, as they become available.
The Clinical Trial Manager provides operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs.
The Contract Clinical Trial Manager will help establish new processes and work instructions to ensure consistent, effective, and efficient execution of clinical operation activities.
The Contract Clinical Trial Manager will partner with key stakeholders (internal and external) to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment.
The Clinical Trial Manager may also manage junior staff members as well as develop and participate in departmental training and annual review processes.
This role is on-site in Redwood City, CA.There are two open roles for this position - Contract CTM-Sr. CTM (Oncology) and Contract CTM-Sr. CTM (Diabetes).
Essential Responsibilities:
Education and Experience Requirements:
Given the "small biotech" nature of the Company, cultural fit of the successful candidate is an important criterion for their success at Biomea Fusion.
Desired characteristics include a high level of curiosity, intelligence, ability to work independently, "can do" attitude, and an entrepreneurial spirit.
Strong initiative and follow through are essential for this job.Education/Experience:
Specific Qualifications Include:
Industry:
Employment Type:
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Expected hourly rate is $80 to $110 per hour, compensation dependent on experience.
