Senior Clinical Trial Manager

San Francisco, CA

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
  • Oversee and manage all aspects of a clinical trial in accordance with SOPs, ICH/GCP regulations and study-specific manuals and procedures 
  • Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable
  • Develop and manage effective relationships with key study stakeholders
  • Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.)
  • Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with SOPs 
  • Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management
  • Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately
  • In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary
  • Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents
  • Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock
  • Project and coordinate study supply and packaging requirements
  • Manage expert consultant activities for study related activities, including effective communication
  • Identify program/resource gaps and proposes solutions
  • Provide weekly enrollment and program updates to senior management

EXPERIENCE

  • Eight to 10 years in the pharmaceutical industry is required, including but not limited to four years overseeing trial management
  • Must have demonstrated problem solving abilities and strong organizational skills
  • Excellent written and verbal communication skills
  • Strong experience with MS Office
  • Excellent working knowledge of FDA & ICH GCP regulations and guidelines
  • Must be a demonstrated self-starter and team player with strong interpersonal skills
  • Must possess excellent cross-functional clinical project management skills
  • Demonstrated ability to develop and implement SOPs and Study Plans
  • Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices

EDUCATION

  • A Bachelor’s degree or equivalent is required (life science degree is preferred)

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.

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