Clinical Trials Manager I

Cytokinetics; San Francisco (CA); Hybrid; USD 124,000 - 145,000; Full time

Benefits offered by this job

Stock options

Health, dental, vision insurance

401k with employer match

Learning & wellness stipends

Paid time off

Job summary

Cytokinetics is seeking a Clinical Trials Manager I to support planning, execution, and oversight of clinical trials in a hybrid work environment. The role emphasizes regulatory compliance, study startup, and coordination with CROs and vendors.

With 1–3 years of clinical research experience and strong communication and problem-solving skills, you’ll contribute to Phase II/III programs and ensure trials stay on time and within budget in the San Francisco Bay Area.

Qualifications

• BA/BS in science-related field is required.
• 1–3 years of clinical research experience (e.g., CRA, CTA, or project support); sponsor-side experience preferred.
• Strong knowledge of ICH-GCP and FDA regulatory requirements.
• Proficiency with MS Word, Excel, and presentation software.

Responsibilities

• Coordinate and support multiple clinical studies per project assignments.
• Apply FDA regulations and ICH guidelines to ensure compliant trial conduct.
• Support Phase II/III programs with a focus on clinical operations.
• Assist in study start-up, site selection, regulatory packages, and investigator materials.
• Monitor CROs/vendors, shipment tracking, budgets, and timelines.
• Attend cross-functional meetings and provide vendor management input.
• Maintain study documentation and TMF quality with operations team.

Skills

Written & verbal communication

Problem solving

Time management

Travel readiness

Education

BA/BS in science-related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.The Clinical Trials Manager I (CTM I) will provide operational support and coordination for the planning, execution, and oversight of clinical trials for Cytokinetics clinical program. Working under the guidance of senior team members, the CTM I ensures that clinical studies are conducted in compliance with regulatory guidelines, internal SOPs, and timelines.ResponsibilitiesManage various activities associated with multiple clinical studies in accordance with designated project assignmentsApply working knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conductSupport significant Phase II or Phase III program with a focus on clinical operationsParticipate in the design study related documents (or sections therein) including but not limited to clinical protocols, case report forms, site study manuals, project tools, monitoring plans, tracking tools, informed consent formsSupport of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directedParticipate and support the conduct of cross-functional study management team meetings, study operations team meetings, and teleconferences with study vendorsManage study-specific CROs and vendors including but not limited to coordinating shipment and tracking of study-related materials to and from investigational sites, vendors, and central labs.May support co-monitoring of sites as required by needs of projectAttend scientific meetings as a representative of Cytokinetics clinical operations teamProvide critical insight regarding evaluation and selection of CROs and other outside vendorsCoordinate efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other Cytokinetics departments as appropriate.Coordinate efforts in all stages of study conduct (enrollment, follow-up, close-out) and oversee clinical operations team and CRO/vendors to ensure the study achieves its goals on time and within budget.Collaborate with Finance, Clinical Outsourcing Manager, and line manager on vendor and study site budget tracking and complianceUse well-developed problem-solving skills to address needs of the program and provides guidance to other lower level personnelMay participate in interviews of Clinical Operations candidates (FTEs and contractors) and provides feedback to hiring managerMaintain TMF documentation quality in coordination with Clinical Trial Assistants and TMF leadsQualificationsBA/BS in science-related field required.1-3 years of experience in clinical research (e.g. CRA, Clinical Trial Associate, or project support roles); sponsor-side experience preferred.Strong written and verbal communication skillsStrong problem-solving skillsBasic understanding of ICH-GCP and FDA regulatory requirementsAbility to work under pressure and deal with time demands; good time management skillsAbility to appropriately assess prioritization of assigned activitiesAbility to proactively identify issues and address with solutions-oriented approachProficient in use of Microsoft applications such as Word, Excel, Power Point, etc.Ability to travel important as the position could require approximately 20% time spent in business travel#LI-HYBRIDPay Range:The expected salary range for this position based on the primary location of South San Francisco, CA is $124,200-$144,900. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and OffersRecently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:We do not conduct job interviews through non-standard text messaging applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail] visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer