Job Description
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development.
Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 70 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.
For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.
Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.
Role Overview
We are looking for a meticulous and dedicated Senior Clinical Trial Associate to join our team at Tenaya. In this role, you will play a critical part in supporting clinical research activities, ensuring compliance with regulatory requirements, and contributing to the successful execution of clinical trials. You will be the backbone of our clinical operations, collaborating closely with cross-functional teams to drive research initiatives that have a direct impact on patient care.
Responsibilities
- Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guidelines.
- Assist in developing, reviewing, distributing, and archiving study-specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.)
- Support the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
- Assist project team(s) with sample management and generate trial progress tracking systems.
- Track and prepare study-specific information utilizing databases, trackers, and other study tools.
- Assist in preparing meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
- Gather investigator and site information to support study start-up, maintenance, and close-out activities.
- Assist in contacting investigator sites to provide study-specific information.
- Serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
- Work with cross-functional study teams and vendors to coordinate clinical trial activities.
- Liaise with cross-functional teams to process shipments and returns and assist with in-house drug, specimen, and ancillary supply reconciliation.
- Support other clinical operations activities as appropriate.
Required Skills/Abilities
- Excellent organizational skills with a keen attention to detail
- Strong written and verbal communication skills
- Experience in managing multiple concurrent clinical trials
- Knowledge of GCP guidelines and ICH regulations
- Certification from a professional organization (e.g., ACRP, SOCRA) is a plus
- Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) tools
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Experience with statistical analysis software is a plus
- Ability to work collaboratively in a team-oriented environment
- Proactive problem-solving skills with a focus on achieving results
- Strong interpersonal skills and the ability to build relationships with diverse stakeholders
- Demonstrated ability to handle sensitive and confidential information
- Flexibility and adaptability in a dynamic work environment
Education and Experience
- Bachelor’s or Master’s degree in a life sciences field or a related discipline
- 3+ years of experience in clinical research or a clinical trial environment
- Strong understanding of clinical trial processes and regulatory requirements
- Proficient in using electronic data capture systems and clinical trial management software
Tenaya takes into account a wide range of factors when determining compensation including not limited to skill sets, experience, interview performance and organizational need.
We will make an offer based on geo-located salary bands based on data collected from Aon/Radford. As of 1/1/2023, for individuals assigned and/or hired to work in the San Francisco Bay Area in the state of California, your base salary will fall within the band(s) below. This base salary range is an estimate, and the actual base salary may vary based on Tenaya’s compensation practice. Please also keep in mind that the benefits, bonus, and the equity portion of your offer is not included in these numbers and represents a significant portion of your total rewards package at Tenaya. Should you reach the verbal offer stage of Tenaya’s hiring process, we will review the base salary, benefits, bonus target and equity grant value with you at that time. Senior Clinical Trial Associate range is $115,500 to $140,000.
Benefits
We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.
State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.
Tenaya is proud to be an equal opportunity workplace.
