Advanced Clinical Hiring For Clinical Trial Manager at Brisbane, CA  Full Time

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Manager in Brisbane, California. This position is responsible for the operational execution, oversight, and management of one or more clinical trials from start-up through close-out. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Manage protocol execution and all operational aspects on one or more clinical trials from start-up through close-out while following SOPs and ensuring compliance with country regulations and ICH/GCP guidelines
• Oversee CRO interactions, including oversight of operational functional activities (study management, site monitoring, site management, etc.)
• Partner with Clinical Business Outsourcing (CBO) on CRO/CSP selection process for outsourced activities including RFP development/review, bid defense meetings, CSP performance, and issue resolution
• Serve as CSP lead for one or more CSPs and manage one or more country/region on global clinical trials
• Collaborate with study lead, Operations Portfolio Lead (OPL), CBO, and finance to develop/manage CRO and other CSP contract/budgets, forecast financials for CSPs, and overall study
• Reconcile invoices against accruals and ensure accuracy of work order and change order updates
• Direct Study Management Team (SMT) meetings and Clinical Operations team meetings
• Lead development of internal and external study documents/plans including, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, and pharmacy manual
• Provide input/support in development and review of key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), and NDA submission
• Work with Portfolio lead to develop, manage, and track study timelines against study milestones
• Communicate timeline risks to all internal and external stakeholders
• Prepare study status metrics and risk mitigations for senior management
• Identify potential study risks, recommend mitigation strategies/solutions, and facilitate discussions for implementation
• Participate in and ensure quality clinical data review and data integrity for assigned clinical trials
• Serve as lead subject matter expert (SME) on various company working groups and participate in the development, review, and implementation of departmental SOPs and processes
• Ensure the clinical trials are always inspection ready and participate in Quality Assurance and/or regulatory authority inspection audits
• Partner with Clinical Operations Excellence and Digital Innovation group to implement innovative ideas to improve clinical trial management process and outcomes
• Organize and present at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings
• Verify that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews
• May require occasional domestic and international travel

EXPERIENCE

• Demonstrate communication, collaboration, and organizational skills with an ability to manage and influence stakeholders in a matrix environment effectively
• Exercise good judgment and make decision that is appropriate for the organization
• Results-driven, take initiative and ownership to accomplish work
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
• Strive for continuous improvement and embrace innovative ideas in daily work
• Ability to work in a strong team-oriented environment and effectively develop collaborative internal/external relationships
• Detail-oriented mindset without losing sight of the big picture
• Excellent project management and leadership skills with ability to manage multiple projects, complex timelines, and shift priorities quickly while working under tight deadlines in a team environment
• Detailed knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
• Strong experience in management of CROs and other CSPs
• Demonstrated coaching skill to develop team
• Proficient in MS Office (Outlook, Word, PowerPoint and Excel) and experience with Smartsheets preferred
• Minimum of 6 years of clinical trial experience required
• Prior experience as a study coordinator or CRA preferred
• Experience working within a small biotech company preferred

EDUCATION

• Minimum of Bachelors Degree of Science or Bachelors of Arts in a relevant scientific discipline required

To 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. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding 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.

It is Advanced Group’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.