Clinical Study Manager

San Diego, 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 a Clinical Study Manager. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Provides management of clinical research studies across all functional areas of the drug development process
  • Oversees and coordinates the operational aspects of new and ongoing clinical studies to ensure corporate goals of time, cost, and quality expectations are met
  • Assures that clinical studies are compliant with ICH/GCP
  • Works primarily as a member of the project team and individually as tasks dictate
  • Supervises Clinical Research Associates (CRAs) as needed - provides guidance and training
  • Works within clinical development and other functional areas to develop protocols, CRFs, ICFs, and other study related documents
  • Oversees preparation of RFPs and prepares bid templates to facilitate selection of the CROs/vendors
  • Collaborates with counsel to negotiate and draft research contracts and agreements with CRO's/vendors and clinical study sites, as needed        
  • Prepares the project plan/timelines and monitors against project progress; ensures project activity compliance with plan. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc. Takes corrective action where necessary
  • Develops and maintains standard operating procedures for Clinical Development that facilitates the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards
  • Liaises with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed

EXPERIENCE

  • Minimum eight years’ relevant industry experience in clinical/medical research, nursing or pharmaceuticals/devices
  • Minimum five years' of prior clinical research experience 
  • Must have a demonstrated track record of effective clinical conduct of clinical studies
  • Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
    • Site selection
    • Study initiation procedures
    • Clinical monitoring functions
    • Drug safety and regulatory affairs issues
    • Data flow from sites to data processing, review, and resolution
    • Analysis and report generation
    • FDA regulatory requirements (i.e. GCPs, CFRs, etc.)
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential
  • Effective communication and interpersonal skills
  • Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
  • Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or project requirements
  • Computer skills should include proficiency with Microsoft Office suite of software

EDUCATION

  • Bachelor’s Degree required (oncology experience 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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