Clinical trial manager Jobs in Rochester, NY

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 doingWe are seeking a detail-oriented and proactive Clinical Trial Associate to support the planning, execution, and management of clinical trials. This role involves assisting with trial documentation, coordinating with internal and external stakeholders, and ensuring compliance with regulatory guidelines. The ideal candidate will have strong organizational skills and excellent attention to detail.You will be responsible for...

• Administrative and project support for Clinical Operations
• Assist in the planning, initiation, and execution of clinical trials in compliance with regulatory requirements (FDA, ICH-GCP, etc.).
• Support the maintenance and organization of trial master files (TMF) and essential documents.
• Support study start-up activities, including site selection, ethics committee submissions, and contract execution.
• Coordinate communication between study sites, sponsors, CROs, and other vendors.
• Track and manage study documents such as informed consent forms, protocols, case report forms (CRFs), and investigator brochures.
• Assist in preparing study materials, site training documents, and monitoring visit reports.
• Monitor trial progress and ensure timely data collection and entry.
• Assist in budgeting, invoicing, and financial tracking for clinical trials.
• Ensure compliance with company SOPs, Good Clinical Practice (GCP), and other applicable guidelines.What Knowledge & Experience you'll bring to us...
• Current knowledge of FDA and ICH Guidelines, including Good Clinical Practices (GCP) requirements
• Excellent communication and collaboration skills to work with cross-functional teams.
• Strong attention to detail and organizational and time management skills
• 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%)
• Excellent communication and interpersonal skills.
• Must be able to write clearly and summarize information effectively.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.