Manager Clinical Compliance and Training

Who we are...Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.What you'll be doingThe Clinical Compliance and Training Manager role is vital in maintaining and enhancing the quality and efficiency of clinical trials. This position is responsible for ensuring that clinical trial activities are conducted in compliance with regulatory guidelines, company policies and SOPs, and Good Clinical Practice (GCP) standards. The individual in this role will implement and oversee quality control processes, drive continuous improvement initiatives, and play a crucial role in ensuring the overall success of clinical trials. A large focus of this role will include supporting oversight and management of Essential Document collection in study Trial Master Files. This individual will also coordinate training for the clinical team to ensure all team members are trained on SOP and regulation.You will be responsible for...

• Quality Control and Compliance
• Monitor clinical trial activities to ensure they meet all regulatory requirements (FDA, EMA, ICH-GCP) and internal standard operating procedures (SOPs).
• Conduct regular review and quality checks on trial processes, documentation, and deliverables to ensure accuracy, completeness, and compliance with protocols.
• Oversee clinical system use and management, including implementation, maintenance, and end user training.
• Ensure all trial-related documentation is inspection-ready and compliant with regulatory standards. Additional responsibilities may include the upload, review, and approval of TMF documents, co-authoring and managing TMF documents such as TMF management Plan, Index, SOPs, and other guidance documents and ensuring quality management by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues (e.g., CAPAs).
• Manage the set-up of any TMF with vendors to ensure adequate implementation, including review process, ensuring TMF completeness and supporting the transfer of the TMF upon study closure.
• Act as a liaison between clinical operations and quality assurance teams, ensuring alignment on quality standards and goals.
• Analyze key quality metrics (e.g., protocol deviations, audit findings, KPIs from clinical systems) to identify trends and areas for improvement.
• Process Improvement and Optimization
• Identify areas for process improvement within clinical operations, focusing on enhancing efficiency and reducing errors.
• Support corrective and preventive actions (CAPAs) to address any quality issues or deviations identified during audits or reviews.
• Work closely with clinical operations to optimize trial processes and ensure alignment with company goals.
• Use data-driven insights to recommend and implement continuous improvement strategies including as applicable, implementing new technologies, tools, and best practices.
• Stay updated on industry trends, evolving regulations, and innovations in quality management, ensuring the organization remains at the forefront of clinical trial excellence.
• Establish a quality improvement framework to foster innovation and improve trial efficiency and compliance.
• Training and Guidance
• Provide training, guidance, and support to clinical teams on quality control best practices and regulatory compliance.
• Develop and deliver training programs focused on GCP compliance, risk management, and quality improvement initiatives.
• Foster a culture of continuous learning and quality excellence within the clinical operations team.
• Risk Management and Issue Resolution
• Identify and assess risks related to clinical trial quality, including potential regulatory compliance issues.
• Ensure risk mitigation strategies are developed for each study to minimize the impact of issues that could delay or jeopardize clinical trial success.
• Proactively manage any quality-related issues, working closely with study teams to resolve problems efficiently.What Knowledge & Experience you'll bring to us...
• Bachelor's or Master's degree in life sciences, healthcare, or a related field. Certification in quality management (e.g., CQA) is a plus.
• Experience : At least 5 years of applicable industry experience in drug development, preference for experience in a small, start-up environment. Early and late-stage experience (Phase 1-3) also preferred
• Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R2) requirements.
• Proven experience in clinical operations in the pharmaceutical or biotechnology industry.
• Strong experience with the DIA (CDISC) TMF Reference Model
• Strong knowledge of electronic document management systems and document archival systems
• Strong problem-solving, and analytical skills, with the ability to identify risks and propose effective solutions.
• Excellent communication and collaboration skills to work with cross-functional teams.
• Strong attention to detail with a focus on accuracy and thoroughness in quality control processes
• Strong training skills on regulatory or GCP compliance training.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and / or Smartsheet a plus
• Travel may be required (5%)
• Communication & Interpersonal Skills :
• Excellent communication and interpersonal skills.
• Must be able to write clearly and summarize information effectively.
• Must be able to present complex information to various audiences.
• Significant Contacts :
• Internal employees and functional leads
• External service providersBehavioral skills to be successful...
• Problem-Solver - As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.What we have for you!
• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and / or other benefits, depending on the level and position offered.DisclaimerNuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time.Note to all external Recruiters & Staffing AgenciesAll of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.