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Director of Clinical Operations RWE

Employer
Barrington James
Location
France
Salary
€120,000+ (experience dependent)
Start date
23 Sep 2021
Closing date
23 Oct 2021

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Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

Job Details

The Director, Clinical Operations, Real World Evidence is responsible for the operational oversight of real-world initiatives (e.g., Post-marketing Safety Studies, non-interventional/observational studies, Registries, long-term follow-up studies, HEOR, etc.). This leader provides direction within the Clinical Operations department while mentoring and developing Clinical Study Leaders and Clinical Research Coordinators.This individual has the skills and understanding of how research is conducted from the sponsor, site, and CRO perspectives.  In addition, the Director of Clinical Operations Real World Evidence is knowledgeable in the use of mobile technology to enhance operational conduct of studies for study participant and study sponsors.

The Director of Clinical Operation, Real World Evidence oversees Clinical Study Leaders and is responsible for all clinical and operational aspects of each study including allocating resources to each project.

Duties & Responsibilities

Duties include but are not limited to:

Project Guidelines and Communication:

  1. Provides operational support for Clinical Operations
  2. Serves as Program or Project Director for large or complex projects
  3. Serves as supervisor, resource, mentor, trainer and motivator to team members
  4. Oversees real-world evidence studies including assessing quality, financial health and customer relations
  5. Assists with the development of systems and procedures for effective project management and clinical operations
  6. Participates in business development activities as required, including proposal pricing and bid defense meetings
  7. Oversees the proper conduct of real-world evidence initiatives in accordance with SOPs, GPP, GCPs and any other applicable regulations and guidelines.
  8. Establishes and maintains contacts at various management levels regarding clinical operations department or specific projects.
  9. Oversees projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality, GPP and GCP
  10. Defines and oversees timelines, milestones and scope of work limitations
  11. Contributes to continuous process improvement across the departments

Project Analysis and Management

  1. Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks
  2. Helps to develop, manage, and oversee adherence to project budget and contracts and assists in the identification and development of scope change documents
  3. Oversees and responsible for project status, timelines, and budget expenditures; identifies potential problems and initiates solutions.
  4. Approves project grants, expense reports and financial records (invoicing/units/expenses)
  5. Supports Clinical Study Leaders in assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget
  6. Ensures contracting processes are completed in accordance with project timelines and cost parameters
  7. Ensures compliance of vendors with study protocols, GPP and GCP, worldwide regulatory requirements, SOPs and company policies, quality standards and guidelines
  8. Serves as a real-world evidence subject matter expert in quality audits (from internal functions and external regulatory bodies), as well as in regulatory inspections
  9. Ensure that study activities are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner Leadership
  10. Active member of Clinical Operations Leadership Team
  11. Accountable for development, oversight and delivery of Clinical Operations personnel training in key areas
  12. Mentors and/or assists in coaching/training clinical operations personnel at all levels, including Clinical Study Leaders, Clinical Research Coordinators and/or other study-associated personnel
  13. Conducts performance reviews, calibration sessions and feedback discussions. Performs competency assessments across his/her team and implements and monitors development plans with direct reports
  14. Determines needed program processes and assists in development of training programs for Clinical Operations personnel
  15. Establishes and communicates team performance expectations and guidelines
  16. Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility
  17. Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned 

Qualifications

  1. Bachelor’s degree required. Advanced degree or equivalent clinical operations experience preferred
  2. 10+ years of pharmaceutical-, biotech- and/or medical device-sponsored operations experience (or equivalent) and/or research background in a supervisory role
  3. Medical and scientific knowledge required 
  4. Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone focus. Ability to have difficult/crucial conversations. Understands interpersonal and group dynamics and has a range of interpersonal skills and approaches with ability to select a best fit-approach.

Capabilities

  1. Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
  2. Ability to communicate in English (both verbal and written)

Direct Reports

  1. Senior Clinical Study Leaders
  2. Clinical Study Leaders
  3. Senior Clinical Research Coordinators (as needed)
  4. Clinical Research Coordinators (as needed

Benefits 

  • Attractive salary and package
  • Full healthcare and bonus opportunities
  • Flat structure and family environment
  • Flexible working environment
  • Fully remote 
  • European-based company 

Following your application Joseph Pearce, a specialist Clinical Operations Recruiter will discuss the opportunity with you in detail. 

He will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can progress further to discussing other opportunities, which are also available right now or will be imminently becoming available.

Please click ‘apply’ or contact Joseph Pearce for any further information

Joseph Pearce

Recruitment Consultant - Clinical Operations EU

Email: jpearce@barringtonjames.com

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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