Sr. Clinical Trial Manager

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.

You will be responsible for…

• Plan and organize the implementation of clinical studies to ensure that the studies are delivered on time, on budget and to quality as expected from planning, initiation, implementation, to completion.
• Organize clinical study teams and identify appropriate external vendors.
• Plan and manage clinical study budgets.
• Develops and tracks quality and risk management plans for clinical studies, organizes feasibility studies at the study, country and/or study center level, identifies participating countries and/or study centers, and develops subject recruitment strategies.
• Responsible for the preparation of clinical operation related documents, including clinical study required documents, ethics committee review materials, genetic resources related filings, and domestic and international clinical trial disclosures.
• Promote the establishment and operation of scientific committees or advisory boards related to research support.
• Develop the supply and management plan of clinical research drugs and equipment.
• Organize investigator/monitor meetings and ensure that they receive adequate and appropriate training
• Develop clinical monitoring plans and oversee their implementation and ensure the quality of clinical monitoring through co-monitoring or other means.
• Cooperate with audit planning and execution and assist in the inspection activities of regulatory authorities when necessary.
• Organize regular internal and external meetings to maintain good communication and cooperation with internal study teams and external vendors.
• Regularly review clinical trial required documents to ensure their completeness and archive within the required timelines.
• Regularly report on study progress, milestones, and major risks and issues

What Knowledge & Experience you'll bring to us...

• Bachelor degree or above in life science related field, preferably in clinical medicine or pharmacology.
• 5 years or more clinical research related experience, preferably in clinical research projects or quality management.
• Experience in clinical research, familiar with ICH GCP and NMPA GCP, working experience in foreign pharmaceutical companies is preferred
• Strong communication and coordination skills.
• Excellent oral and written English.

Behavioral 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
• up to 15 OPT and 12 Sick Days Annually
• Excellent Medical Coverage
• Social Security and Provident Fund
• and much more!

Disclaimer

Nuvation 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 Agencies
All 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.