Senior Clinical Operations Leader

Employer
Parexel
Location
Romania
Salary
Competitive
Start date
12 Jan 2023
Closing date
11 Feb 2023
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Job Details

The Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Clinical Operations deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of the clinical operations strategy on the project. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. This position is responsible for coordination of clinical team for a small to midsize project(s) and therefore acts as a role model and/or coach for the team. This position can also be part of a global project management team.

Key Accountabilities:

Client Liaison
  • Effectively communicate with internal and external customers as well as third party vendors
  • Prioritize effectively and respond to urgent requests within team or from sponsor.


Project Initiation & Planning
  • Manage study start-up activities
  • Provide input to project tools, PL project plan, Central File Maintenance Plan
  • Provide input to the format and content for sponsor reports
  • Provide input to and oversight of site selection strategy plan
  • Develop site selection and monitoring plans for the team
  • Review and provide input into patient recruitment plan and retention plan
  • Establish efficient / effective working relationships with other functional Leaders and coordinators across geographieswithin a given program
  • Develop study plans, tools and forms


Project Implementation, Control & Evaluation
  • Provide leadership and direction to project team members
  • Evaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle of project
  • Provide productivity targets to project team members
  • Early recognize areas of potential problems and provide input to contingency plans
  • Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
  • Maintain and assure quality of work generated and escalate and follow up as appropriate
  • Implement and instigate process improvements within the project
  • Provide input to the Revenue Recognition forecast
  • Identify changes in scope and liaise with Project Leader
  • May be required to conduct site visits as per client or project demands
  • Participate in client, investigator and team meetings
  • Prepare, participate in and follow up on audits / inspections


Project Close-out
  • Collaborate with project team (e.g. Project Leader and Data Operations Leader) on database lock activities
  • Together with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out Checklist
  • Together with Project Leader ensure project is archived and all documentation returned to the client as specified by the contract
  • Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions


Operational
  • Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatoryrequirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedure
  • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense claims)


Qualifications
  • Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trials.
  • Degree in a life science, nursing qualification or relevant experience
  • Competent in written and oral English
  • Strong understanding of the cross functional activities
  • Leadership skills
  • Strong customer focus
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Effective time management in order to meet daily metrics or team objectives
  • Personal skills that include: ability to take initiative and work independently, ability to successfully work in a team environment, sense of urgency in completing assigned tasks
  • Excellent interpersonal, oral and written communication skills
  • Excellent presentation skills
  • Ability to travel as required

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Find Us
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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