Director of Clinical Operations Study Management

Company: Advanced Clinical
Location: Hayward
Posted on: September 20, 2023

Job Description:

OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Director of Clinical Operations Study Management in Hayward, CA. The Director of Clinical Operations Study Management will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management of clinical studies and support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Development teams to ensure successful completion of studies within timelines and budget, with a focus on high quality to support operational excellence and world class clinical study management. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.RESPONSIBILITIES

• Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies
• Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution
• Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines
• Manage study budgets, timelines, and resource allocation to ensure successful completion of studies
• Develop and maintain strong relationships with study investigators, clinical research organizations, and other external partners
• Provide regular updates on study progress to senior leadership and other stakeholders
• Ensure that all study-related documents are accurate, complete, and filed appropriately
• Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high impact results. Embrace metrics and high-performance standards
• Manages, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Serves as in-house contact for protocol-related process questions
• Audits clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations
• Contributes to the SOP review process
• Demonstrates excellent knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies and coaches junior staff
• Ensures the Trial Master File is maintained throughout the study
• Manages direct reports and monitor assigned activities
• Provides frequent study updates to senior management
• Practices professionalism and integrity in all actions and relationships with client management, supervisors, team members, direct reports, and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact. Demonstrates ability to foster teamwork, cooperation, self-mastery, and flexibility to get the work done. Maintains composure under difficult circumstancesEXPERIENCE
  • At least 8 years of experience in clinical operations, including experience managing clinical studies in oncology, and managing Clinical Operations personnel
  • In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines
  • Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety
  • Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams
  • Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery
  • Experience managing external vendors and clinical research organizations
  • Ability to work onsite at least 3 days a weekEDUCATION
    • Bachelor's or advanced degree in a relevant scientific or healthcare fieldTo be a best-fit your strengths must include:
      Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
      Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
      Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
      Problem-Solvers. 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. Detailed understanding of clinical methodologies and ability to provide sound analytical support, you quickly establish credibility as a reliable resource.About Advanced Clinical
      Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutionsRegarding your application
      Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.Equal Employment Opportunity
      It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Keywords: Advanced Clinical, Hayward , Director of Clinical Operations Study Management, Healthcare , Hayward, California