Clinical Trial Manager

iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.

iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic. At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.

The Clinical Trial Manager is responsible for clinical operations leadership for assigned pre-market studies with a high degree of complexities, including protocol development and study planning, implementation, execution and close-out activities. The Clinical Trial Manager drives and supports initiatives to enhance operational efficiency and excellence to ensure the program meets or exceeds the timelines and deliverables established and assigned. The position ensures the Clinical Operations departmental standard-operating procedures and clinical investigational plans comply with and adhere to Good Clinical Practices and all applicable regulations to meet the company and clinical departmental objectives.

iota offers a very competitive benefits package that includes the following:

Health & Wellness

Comprehensive health coverage for you and your family, covered at 100%

Access to quality dental and vision

Onsite Gym in Alameda

Work-Life Balance

Generous vacation pay

Paid parental leave

Options for flexible work schedules

Competitive Compensation

Annual Bonus Plan

Long Term Incentive Plan (LTIP)

401k plan with employer match

Core Responsibilities:
· Perform detailed review of relevant regulatory standards and guidance documents to ensure appropriate development of Clinical Investigational Protocols and SOPs
· Develop and implement clinical SOPs, templates, forms and plans commensurate with the stage of iota’s device programs
· Help define, drive and implement strategy for execution of clinical trials, which may include resource planning, vendor oversight, monitoring and development and maintenance of study timeline projections
· Manage day-to day operations of assigned SOPs and studies, including coordinating cross-functional inputs to assure progress, problem resolution and timely completion
· Communicate effectively with Investigators, and study site personnel to implement Clinical Investigational Protocols and support study enrollment and execution goals
· In collaboration with other teams, help drive development of Clinical Investigation Protocols and related clinical documents required for regulatory submissions, including but not limited to informed consent forms, clinical monitoring plans, and DSMB/CEC charters
· Help manage clinical vendors/suppliers (e.g., Contract Research Organizations (CROs), central laboratories/readers)
· Assist with site recruitment process and participate in Site Qualification Visits (SQVs) to evaluate the ability of the site to successfully manage and conduct the clinical study
· Oversee the collection, organization, and maintenance of up-to-date essential documents, site activation checklists, regulatory documents and training requirements
· Review and approve investigational site monitoring visit confirmation letters, monitoring reports, and IMV/close-out visit letters
· In collaboration with the CRO/monitoring team, liaise with study site personnel to ensure timely and accurate data entry, including the timely resolution of data queries
· Assist with the development and management of study-specific resources (e.g., study reference guides, manual of operations, master trackers, training decks)
· Create dashboards to track project progress including but not limited to study start-up activities, site activation, ramp-up, enrollment, participant status, incidence of AEs & device deficiencies, eCRF completion, IRB-approvals/reporting, laboratory sample management, and efficacy readouts
· Proactively identify at-risk deliverables and timelines; propose solution driven ideas to ensure project deliverables are met within expected timelines
· Provide input as issues arise during implementation of clinical study with special attention to ensuring sites comply with the clinical investigational plan and instructions for use as well as applicable federal regulations
· Help manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing creative solutions (e.g., study-site webinars, newsletters)
· Oversee site investigational device and study supply inventory, storage, and accountability (e.g., implant kits, laboratory kits, demos)
· Help plan and coordinate Investigator Meetings and other study-specific training
· Participate in internal and external clinical quality assurance audits
· Operate at the highest level of iota/Astellas compliance and professional standards in cross-functional and external activities
· Other tasks as reasonably requested

Minimum Qualifications:
· Bachelor’s Degree in a Life Science, pre-medicine, nursing, engineering or related academic field
· Thorough knowledge and understanding of clinical trials with a minimum 5 years of experience in the planning and managing of medical device or pharmacological clinical programs, including at least 5 years for Class III active implantable medical devices
· Thorough knowledge of GCP, ICH guidelines and FDA regulations and application in the medical device industry
· Can foster creative thinking, innovation, knowledge sharing and reasoned risk-taking
· Ability to travel (average travel expectations approximately 35%)
· Strong written and verbal communication; strong interpersonal skills
· Self-motivated, assertive and able to function both independently and collaboratively as part of a team
· Able to complete tasks independently and efficiently with high attention to detail and in a timely manner
· Strong organizational skills, detailed oriented, and able to multitask and work effectively in a fast-paced environment
· Creative approach to problem solving and able to work effectively in a constantly changing environment