Skip Navigation

Jobs at Parexel

Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Clinical Operations Leader

Job ID 59949BR Poland - Any Region - Home Based
This role can be based in multiple EMEA locations - Croatia, Lithuania, Poland, Romania, Serbia, Russia, Turkey, Ukraine.

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 geographies
within 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

Operational
• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory
requirements 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

Join our Talent Community

Welcome to the Parexel Talent Community! Sign up below and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.

Recently Viewed Jobs

You have not recently viewed any jobs

View all jobs

RECRUITMENT FRAUD ALERT

It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.