Clinical Lead I / Clinical Lead II (Home-based in the US)
premier-research
 San Francisco, CA

Can you imagine anything more fulfilling than bringing unimaginable treatments to patients? Neither can we.

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic Clinical Lead to join our team.  A team that ranks among the top five contract research organizations for consistently delivering services that meet customer expectations.

As a Clinical Lead, you will have the opportunity to make a great impact on the most innovative programs in our industry. You’ll direct, supervise and support all clinical staff on the project team; liaise with the customer’s clinical team and collaborate with project team members in other functional areas to ensure delivery within contractual obligations and Premier's standards of excellence. 

You’ll be accountable to:

  • Drive the successful activation of trial sites according to time, quality/scope and budget parameters
  • Understand the proper escalation points based on the circumstances and keeps other departments informed of developments affecting their functions
  • Plan and drive both patient recruitment and retention, together with the PM
  • Ensure that the clinical team adheres to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements
  • Take the initiative to move the project/program forward and leads in country and global projects where applicable
  • Lead and manage the clinical monitoring teams with focus on quality and timely deliverables
  • Work with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
  • Plan and conduct initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance
  • Apply clinical and monitoring expertise in the design of case report forms
  • Create and maintain a study specific clinical monitoring plan (CMP)
  • Prepare and execute a site and patient recruitment and retention plan
  • Serve as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
  • Ensure effective communication plans are in place for the clinical team and are actioned
  • Monitor the preparation and timely completion of all monitoring visit reports, review them for appropriate content, and ensure effective follow up and resolution of site issues
  • Monitor the quality of clinical deliverables and address quality issues with the appropriate team member
  • Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
  • Escalate issues and provide escalation path for the team
  • Perform any other duties required to ensure the success of the trial and Premier Research
  • May serve in a dual CM/PM role on smaller studies

 

You’ll need this background to be considered:

  • BS degree and 6 years of clinical research experience as a CRA, CM or PM (2 years of Clinical Trial Management or Lead CRA responsibilities as well as 2 years onsite monitoring or 3 years remote monitoring experience) is required
    • If no degree, 8 years of clinical research experience as a CRA, CM or PM of which 6 years of clinical monitoring experience is required
  • Presenting information to various levels of stakeholders
  • Providing performance feedback on CRAs for annual appraisals
  • Effectively communicating expectations using proper oral and written language
  • Experience in managing complex or global trials
  • Budget/finance experience on a project level and demonstrates a full understanding of project financials
  • Professional and interpersonal skills with the energy, vision and drive to motivate and manage a number of stakeholders and contributors to meet deadlines and to deliver services
  • Ability to establish and maintain effective working relationships with colleagues and customers
  • Enthusiasm and willingness to accept responsibility, take ownership of assigned projects and see them through to on-time completion
  • Detail oriented and well organized with excellent task organizational skills
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities