Senior Clinical Operational Lead

Wilmington, DE

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Operational Lead in Wilmington, DE.  The Senior Clinical Operational Lead role will report to the Executive Director of Clinical Operations, and will support the Clinical Trial Manager and Operational Team during execution of the trial. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Assist in the development and writing of clinical trial documents and manuals
  • Participate in the evaluation of investigative sites
  • Coordinate and monitor activities at investigational sites
  • Review monitoring trip reports and conduct co-monitoring visits as needed
  • Assist in the development and management of study timelines and priorities 
  • Review data and resolve discrepancies 
  • Participate in coordinating efforts with internal PV, safety group
  • Monitor study-specific timelines and key deliverables
  • Join the Multi-Disciplinary Project Team
  • Participate in team study meetings, training, Investigator Meetings, and other relevant activities
  • Function as the primary clinical liaison between the Clinical Drug Development Team and other departments
  • Contribute as a member of a working group and perform special projects as assigned, to improve the efficiency, effectiveness, and functional quality of the department 

EXPERIENCE

  • Minimum five years experience in the biopharmaceutical industry or other relevant clinical research experience
  • Minimum two years clinical monitoring experience
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience 
  • Experience in the conduct and management of multinational clinical trials is preferred

EDUCATION

  • Minimum of Bachelor’s degree, with strong emphasis on science

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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