Clinical Lead

Your qualification:

Education: Degree in a life science, nursing qualification or relevant experience.

Minimum Work Experience: Substantial experience in clinical research including relevant experience in a CL function or proven experience in coordinating clinical trials.

Skills:

-Excellent interpersonal, verbal and written communication skills;
-Competent in written and oral English;
-A flexible attitude with respect to work assignments and new learning;
-Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail;
-Ability to identify and address issues proactively in a timely manner;
-Willingness to work in a matrix environment and to value the importance of teamwork. Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability;
- Ability to motivate both individuals and a team;
- Financial understanding (category 1 and 2) and ability to manage a budget (category 2).
- Ability to take initiative, work independently and delegate;
- Accountability for all assigned tasks;
-excellent computer literacy.

As Clinical Lead (CL) responsibilities includes managing clinical monitoring activities and liaising with project management and the sponsor (if appropriate) to ensure that the clinical deliverables are met.
The Clinical Lead Role is one suitable to either a very experienced CRA II or a Senior CRA who has demonstrated organizational and leadership skills.

This role, according to business need, can be divided into two categories:
Category 1 : the Clinical Lead (Full Service Project) co-ordinates the clinical team and supports the Project Manager on a large, complex, full service project.

Category 2: the Clinical Lead (Stand-alone Project) has full, including financial responsibility for a small/medium size project (typically monitoring only) and in fewer countries.

Key Accountabilities :

•Directing clinical project team.
•Able to review project information in BESTT, provide input to/develop project plan and project tools.
•Early recognition of areas of potential problems and formulate contingency plans.
•Evaluate and identify resourcing needs and provide performance feedback as appropriate.
•Organise and participate in client, investigator and team meetings.
•Identify and facilitate study training needs.
•Review of visit reports.
•Monitor study timelines and patient recruitment to ensure successful outcome of the project.
•May be required to monitor site(s) as per client or project request.
•Maintain and assure quality of work generated.
•Participate in preparation of audits/inspections and audit itself
•Is responsible for Central File Management and QC
•Compile monthly reports in a timely manner.
•Awareness of Revenue Recognition and associated timelines.
•Effectively communicate with internal and external customers as well as third party vendors.
•Participate in Clinical Lead Training as required.
•Establish good working relationships with other functional leads.
•Prioritise effectively and respond to urgent requests within team or sponsor lead.

Category 1: Clinical Lead full service
oreview project portal reports to ensure time spends remain in budget and escalate to LMs and PMs as necessary
oIdentify changes in scope and liase with Project Manager.
oReview expenses reports for clinical pass-through.

Category 2: Clinical Lead standalone:
oContinually monitor budget to ensure project milestones and budget are achieved.
oClosely monitor pass-through costs.
oProactively ensure that all invoicing is completed in a timely manner.
oIdentify and track changes in scope and liaise with Project Analyst

The expertise and passion for excellence shared by our people around the world unite us in our mission and drive our success.
As one of the leading global biopharmaceutical service providers, PAREXEL has a 25-year history of delivering a full range of services and solutions through our offices in 51 countries. In fact, we have helped over 2000 top industry clients to develop and launch some of the most important drugs and devices of our time, bringing new treatments and cures to patients in need. For more information please visit www.parexel.com

How to apply/ contact information:

If you are interested in this engaging and responsible position within an international environment, please submit your complete application documents in English per email to HR-Europe@parexel.com until 27 February.

For further information please do not hesitate to contact Scott Neto, Senior Recruitment Specialist, Project Management , PAREXEL International Ltd
on : +44 (0) 1895 614564.