Manager, Clinical Operations

Rho

  • USA
  • Permanent
  • Full-time
  • 1 month ago
OverviewThe Manager, Clinical Operations will be responsible for oversight and management of commercial (CTO) Research Associate (RA) and In-House Clinical Research Associate (IHCRA) activities and staff, the development of these roles to ensure optimal performance, career development, and retention of top performers. The Manager, Clinical Operations will support the planning, implementation and tracking of ongoing activities and projects within Project Management and Clinical Operations.Responsibilities
  • Provide line management for RAs and IHCRAs. Meet at least monthly with employees to provide mentorship and coaching, and discuss professional development, and opportunities to increase knowledge and skill set
  • Ensure employees are properly onboarded and trained and assist in therapeutic and project specific training as requested
  • For each direct report, maintain retrospective and prospective vigilance of utilization, realization, availability to take on additional work, and paid time off
  • Identify and review quality performance metrics for employees
  • Upon request of project teams, allocate resources to clinical projects based on experience and training according to the available project budgets and assess employee resources, projections and activities to ensure that project teams meet client expectations and contractual obligations
  • Report monthly to CTO leadership on staffing development progress, projections, gaps and potential needs, highlighting key areas of accomplishments, metrics and risks
  • Through analysis of resourcing projections and upcoming work, collaborate with CTO leadership to request requisitions and participate in hiring and interviewing process Provides dynamic mentorship to staff; serves as escalation point and technical expert for staff and clients as needed
  • Make informed and data-driven decisions of their direct reports that result in positive impact on overall business performance
  • Collaborate with project teams and functional area SMEs across sectors, to ensure customer satisfaction, high quality deliverables, and profitability for all commercial projects
  • Support and/or leads the design of cross-functional process efficiencies and develop new approaches to tasks completed by staff
  • Contribute to clinical operations development through participation in special assignments, process assessments and development of project and task aids such as reference materials, training materials, templates, etc.
  • Ensure employee compliance with assigned trainings; collaborates with the Organizational Development team to manage, plan, create, and present learning and training opportunities for current and future employees
  • Provide training by implementing effective orientation, mentoring, and career development opportunities; assist in therapeutic and project specific training as requested
  • Ensure staff fulfill their responsibilities in accordance with policies, procedures, SOPs, ICH-GCPs, and country specific regulatory requirements
  • Stay current on clinical operations and industry trends and how these may impact staff development and clinical management approaches, working closely with the CTO Leadership
  • Participate in quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives
  • Exhibit Rho’s Core Values at all times
  • Work in accordance with Rho’s Remote Hybrid Work Policy and attend meetings at any of Rho’s offices, sponsor site or client’s office as needed
  • Provide excellent customer service to internal and external clients in a timely and professional manner
  • Respond to email and other communication requests in a timely fashion using a variety of methods including but not limited to email, instant messaging and other communication tools
  • Maintain confidentiality
  • Take initiative to complete project-specific responsibilities with minimal supervision
Qualifications
  • Bachelor’s Degree, preferably in life sciences or related field
  • Minimum of 5 years clinical research experience or relevant equivalent
  • Minimum of 2 years of experience managing RAs, IHCRAs or other clinical support roles, either via direct line management or in a matrix/project management environment
  • Strong understanding of project staffing and typical project management and clinical operations team structures
  • Exhibits clear understanding of the drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Demonstrates effective decision-making skills
  • Experience developing and mentoring staff
  • Proven ability to balance competing priorities; ability to see patterns in issues, discount non-issues and prioritize to make progress
  • Proactive and effective communicator
  • Ability to identify issues within a project and lead the team to resolution
  • A subject matter expert in the tasks typically assigned to these staff
  • Strategic thinker and active problem-solver
  • Ability to bring order to situations that others may perceive as disjointed
  • Ability to “get things done” in complex situations with minimal oversight
EOE. Veterans/Disabled.

Rho