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.
At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.
The Contract Clinical Systems Manager is responsible for supporting the lifecycle management of clinical systems for Development Operations. This position will provide oversight of clinical study vendor GxP systems and manage internal clinical systems, such as the Clinical Data Repository (CDR), eTMF, Clinical Trial Management System (CTMS), EDC, and other digital technologies used in clinical trials.
The Contract Clinical Systems Manager will have expertise and practical experience in clinical trial management and clinical systems. The position will report to the Director of Clinical Systems. This role supports GxP systems validation and vendor management, clinical data integration and other clinical systems, ensuring the development and validation of solutions to deliver on existing programs.
Responsibilities
Lead GxP system evaluations and assess vendor validation packages
Oversee clinical study vendor GxP systems changes and lifecycle deliverables
Ensure clinical study systems comply with applicable regulations and guidance (e.g., 21 CFR Part 11, Annex 11, ICH E6(R2/R3)).
Support internal/external audits and regulatory inspections (including audit trail review strategy).
Maintain inspection-ready documentation
Establish governance for change control, periodic review, and system lifecycle management.
Work on planning, design, configuration, and deployment of new clinical systems and enhancements to existing applications; coordinate and participate in analyzing system requirements, user acceptance testing, and system enhancements, as necessary.
Support the Development Operations team in managing systems vendor relationships on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate.
Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems.
Partner with IT, Quality Systems, and other stakeholders on clinical system bug fixes and upgrades.
Oversee governance for clinical systems, as applicable.
Work with clinical systems vendors and CRO partners to transfer, integrate, and transform clinical data and operational data to Cytokinetics systems.
Qualifications
BS degree in information technology, computer science, computer engineering, statistics, or bioinformatics
7+ years of experience supporting GxP computerized systems in clinical research environments (sponsor, CRO, or biotech).
Strong expertise in GxP validation principles (CSV lifecycle and risk-based validation)
Hands-on experience with major clinical platforms (e.g., Veeva eTMF, Medidata Rave EDC & CTMS, IRT/RTSM, RBQM/RACT, CDR)
Demonstrated experience leading system evaluations, validation deliverables, and UAT oversight
Working knowledge of global regulatory expectations (FDA, EMA, MHRA).
Understanding of clinical trial data and regulations (CDISC, Good Clinical Practice, 21 CFR Part 11).
Experience in developing business specifications/requirements and user acceptance testing for computer systems
Familiarity with database concepts, data validation, and data model process from internal and external sources.
Knowledge of AI technology preferred
Must possess good interpersonal skills
Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required.
Good organizational skills, ability to manage multiple tasks.
#LI-REMOTE
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $110-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 Offers
Recently, 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 applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer