Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

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.

We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, hypertrophic cardiomyopathy, ALS, and SMA.

We view our employees as the unequivocal ingredients to success. Every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular and neuromuscular diseases of impaired muscle function.

The Contract Senior TMF Document Specialist is a key role at Cytokinetics, responsible for overseeing the management and quality control of Trial Master File (TMF) documentation across multiple studies. This role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to study teams and TMF Document specialists. The Senior TMF Document Specialist will also play a key role in inspection readiness, process improvement, and training initiatives. The Senior TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, and Regulatory Affairs, to ensure the accuracy, completeness, and timeliness of TMF documentation.

TMF Document Management & Oversight

• Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements.
• Lead milestone TMF reviews, ensuring that all required documents are accurately filed and accessible.
• staff and study team members on best practices in document management.
• Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.

• Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues.
• Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community.
• Mentor TMF Document Specialist guiding key document attributes (i.e., classification of documents) and resolution of document queries.
• Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible

Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment.

Study Team Support

• Act as a senior liaison between the TMF Manager, TMF Document Specialist, vendors, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle.
• Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index.
• Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues.

TMF Metrics & Reporting

• Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement.
• Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes.
• Provide regular TMF/eTMF status updates during Clinical Vendor Oversight Meetings and Study Operational Team meetings.

Inspection Readiness

• Ensure the TMF complies with all applicable regulatory requirements and guidelines.
• Prepare for and support regulatory inspections and audits related to the TMF.

Qualifications

• Bachelor's Degree Required
• 3+ years of Veeva Vault eTMF experience required.
• 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience with global clinical trials is highly desirable.
• TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications

Key Skills, Abilities, and Competencies

• Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.)
• Experience in managing TMF documents during regulatory inspections.
• Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements.
• Basic understanding of study and site management and overall trial planning and execution.
• Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations
• Familiarity with MS Word, MS Excel (extra plus), and MS PowerPoint.

Core Competencies

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Tolerance of ambiguity and willingness to work through complex issues.
• Strong work ethic, organizational skills, oral and written communication skills, a 'can do' approach, problem-solving skills, and team player skills.
• Ability to multi-task and manage several projects in parallel while paying attention to detail.
• Strong critical thinking skills and ability to contribute creative yet practical solutions to problems.

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

Please visit our website at: www.cytokinetics.com.

Cytokinetics is an Equal Opportunity Employer

Pay Range:

$50-$60/hr

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