Principal Clinical Team Manager

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Principal 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 Principal Clinical Team Manager, you will be accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. You will interpret data on complex issues and make good business decisions with support from line management. You will also work to ensure that all clinical deliverables meet the customer's time, quality, and cost expectations. Additionally, you will:

  • Maintain profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team
  • Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
  • In accordance with project specific requirements, assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities, take on additional responsibilities, or have wider management or project coordination responsibilities
  • Develop clinical tools (monitoring plan, monitoring guidelines) in conjunction with the Data Quality Plan
  • Contribute to the development of the Master Action Plan (MAP) by providing clinical related documents
  • Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central)
  • Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol specific documents
  • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
  • Collaborate with the clinical team and other departments as needed to meet deliverables of the project
  • Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained
  • Be responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
  • Archive documents and study materials for the department in a timely manner
  • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
  • Continuously monitor clinical trials to assess performance and ensure contractual obligations are met
  • Conduct Accompanied Field Visits (AFVs) and be accountable for project financials
  • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues
  • Coordinate all start-up activities and ensure that essential document quality meets the expectation of Regulatory Compliance Review
  • Ensure timely regulatory submissions (if appropriate) are addressed
  • Review and follow up on all questions raised by ethics committees
  • Provide input into preparation of forecast estimates for clinical activities
  • Be responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements

What You’ll Need to be Successful:

  • Bachelor's degree and at least 8 years of relevant experience
  • Strong leadership, mentoring, and training skills
  • Ability to motivate and integrate teams
  • Strong planning and organizational skills to enable effective prioritization of your workload and that of team members
  • Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
  • Solid understanding of change management principles
  • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
  • Strong judgment, decision making, escalation, and risk management skills
  • Effective oral and written communication skills
  • Ability to evaluate your own and team members workload against project budget and adjust resources accordingly
  • Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management
  • Strong attention to detail
  • In-depth understanding of relevant regulations such as ICH/GCP and FDA guidelines
  • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, and Word
  • Ability to independently manage clinical only studies

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: Wednesday, March 10, 2021



Apply to this job
  • 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.