Covance

Clinical Team Lead

NL
Job Number
2017-14727
Job Category
Clinical Operations
Position Type
Temporary

Job Overview

Clinical Team Lead

 

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

 

We are recruiting for our flexible solution team in The Netherlands and are currently seeking to hire a Clinical Team Lead to help support the team and work directly with our client, a large pharmaceutical company.

 

This is a 6 months contract based on a full time position. Candidate looking for 80% will also be considered - based in our client’s office in Gouda.

 

About the Job

Within this position, your duties will include:

Commercial responsibilities

  • Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business as required
  • Develop and maintain relationships with assigned clients and serve as the client interface of all clinical operations matters. Meet /exceed client satisfaction expectations.

Initiation an Planning

  • Sets the project related clinical operations objectives and strategy in collaboration with the Core Team
  • Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list
  • Requests, manages and tracks clinical project resource needs
  • provides clinical operations input into cross functional project plans
  • Develops the reisk and contingency plan for key clinical operations activities in collaboration iwth the Core Team
  • Manages the successful design, implementation, tracking and revision of the monitoring plan and the clinical operation training for assigned projects.
  • Writes the prototype informed consent form
  • Provides clinical support to Global Site Services for regulatory submission and IRB/ERC queries
  • Assists in the design of the CRF, EDC or equivalent
  • owns the development of project-specific site and monitoring tools
  • Owns the development of training materials and training specific to the clinical operations team
  • Develops and presents the clinical operations trainign materials for Investigator Meetings

Execution

  • Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans
  • Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope.
  • Responsible for managing the clinical operations timelines as agreed with the client
  • Participate in internal project review meetings and provides clinical operations update to the project management team
  • Responsible for the clinical management of approved sub-CRO's. May also be requested to manage approved vendors for clinical activities or services
  • Ensures that all clincial operations staff allocated to assigned projects adhere to professional standards and SOPs
  • Ensures appropriate utilization of all assigned clinical operations team members
  • Responsible for timely and appropriate communication to the clinical operations team
  • Provide performance feedback of team members to respective supervisors
  • Ensure accurate and timely trip report completion and trip report review.
  • Review and approve investigator grant payments
  • Follow project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process for clinical operations
  • Responsible for clinical operations Corrective and Preventative Action plans
  • performs comonitoring visits when necessary
  • Ensure timely filing of relevant sections of the TMF.

Monitor and Control

  • Track client project metrics tot the clinical operations deliverables
  • Owns and implements the risk and contigency plans for key clincial operations activities
  • coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives
  • Contribute to improvements to enhance the efficiency and the quality of the wokr performed on assigned projects
  • Track project progress against financial milestones using applicable financial systems. Review Time analysis and provide monthly hourse forecast.

Close-Out

  • Consolidates resources to ensure financial viability during close out
  • Ensures all site issues have been resolved
  • Ensures clinical operations sections of the TMF are complete
  • Coordinates archival of the clinical operations sections of the TMF.

 

About You

To be successful in this position, you will need to hold a University /college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution

Additionally, you will need to demonstrate:

  • ICH/GCP guidelines
  • Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Site monitoring and study site management requirements
  • applicable regional regulatory requirements
  • Trip report review, risk planning, study plan development, resource planning and data management oversight.

 

We Offer

Covance offers a comprehensive benefits package including health cover and contributory pension.

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. 

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

 

Education / Qualifications

Required:

  • University /college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
  • In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Thorough understanding of the drug development process.

Preferred:

  • Working knowledge of Covance SOPs
  • Experience as a Senior Clinical Research Associate, Whether internal or external

Experience

Required:

Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of:

  • ICH/GCP guidelines
  • Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Site monitoring and study site management requirements
  • applicable regional regulatory requirements
  • Trip report review, risk planning, study plan development, resource planning and data management oversight.

 

In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered

 

Additional requirements include:

  • Demonstrated ability to work with minimal supervision
  • Demonstrated good planning and organization skills
  • Good computer skills with good working knowledge of a range of computer packages
  • Demonstrated effecitve and professional verbal and written communication skills
  • Ability to train, lead and develop junior staff
  • Ability to understand and work with financial information.
  • Ability to resolve project-related problems and prioritizes workload for self and team
  • Ability to work collaboratively within a project team
  • Ability to work efficiently and effectively in a matrix environment

Preferred

  • 1+ year additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

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