Clinical Team Manager

Resolvit.com - Raleigh, NC

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Clinical Team Manager and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Clinical Team Manager, you will be accountable for achieving the final clinical deliverable within the time period specified in the contract with the Customer. You will interpret data on project issues and make good business decisions with support from experienced team members or line management. You will also maintain profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. Additionally, you will:

  • Manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP
  • Develop clinical tools (monitoring plan and monitoring guidelines in conjunction with data quality plan)
  • Be responsible for timely set up, organization, content, and quality of the relevant sections of the Trial Master File
  • Participate in the design and development of CRFs, CRF guidelines, and patient informed consent templates
  • Prepare, organize, and present at investigator meetings with the Project Manager
  • Implement and train standardized clinical monitoring processes according to corporate standard policies
  • Be responsible for the timely archiving of documents and study materials for the clinical department
  • Monitor clinical activity timelines and metrics
  • Provide regular status updates to PM for client reports
  • Ensure regular project review using tracking and management tools and implement appropriate recovery actions to ensure project timelines are met
  • Review monitoring visit reports and ensure finalization is within contractual timeline
  • Manages CRF collection and query resolution process
  • Monitor/co-monitor clinical trials as needed to assess performance and/or ensure contractual obligations are met
  • Lead regular conference call meetings with monitors and other clinical team members
  • May participate in bid defense meetings

What You’ll Need to be Successful:

  • Bachelor's degree or licensed certified health care training
  • Significant clinical research experience (comparable to 3 years) in all phases of study life cycle, including start up, interim, and close out
  • Valid driver's license and passport
  • Superior organizational skills
  • Demonstrated performance management abilities
  • Extensive monitoring experience
  • Excellent judgment and decision-making skills
  • Effective verbal and written communication skills
  • Excellent interpersonal skills and problem-solving ability
  • Ability to motivate and integrate teams and teach/mentor team members
  • Ability to effectively prioritize workload
  • Strong attention to detail
  • Expert knowledge of relevant regulations such as ICH/Good Clinical Practices and FDA guidelines
  • Computer skills

Great Additional Skills:

  • Experience as a field CRA
  • CRO/pharma experience

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Monday, October 11, 2021



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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.