Register your interest for a home-based (oncology focused) Clinical Research Manager role with Parexel FSP in the UK.
At Parexel FSP people make a difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
You will play a key role in supporting, coordinating, and conducting local, very sophisticated, oncology clinical trials for our client, a top 10 Pharma business. This includes full involvement in study start-up, maintenance, and closure, as well as vendor management and CRA oversight.
The Clinical Research Manager (CRM) is primarily accountable for end-to-end performance and project management for assigned protocols in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Key Accountabilities:
Client Liaison:
Project Initiation & Planning:
Manage study start-up activities.
Provide input to project tools, PM plan, Central File Maintenance Plan, 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.
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.
Address identified and escalated site issues and drive to closure.
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.
May be required to conduct site visits as per client or project demands.
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, 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.
Skills:
Leadership skills that include:
Ability to lead a virtual team across locations and cultures.
Ability to negotiate and influence with diplomacy in order to achieve results, and to make decisions even in ambiguous situations to achieve project timelines and quality.
Ability to conduct root cause analysis in business problem solving and process improvement development.
Strong customer focus, ability to interact professionally within a client organization.
Effective time management in order to meet daily metrics or team objectives.
Personal skills that include:
Ability to take initiative and work independently and within a team.
Commitment to high quality work and respective consistent performance
Excellent interpersonal, oral, and written communication skills
Excellent presentation and consulting skills.
Business / operational skills that include:
Customer focus and commitment to delivery and quality.
In-depth understanding and experience in the clinical trial process and understanding of all aspects of project life cycle.
Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations.
Knowledge and Experience:
Strong command of written and spoken English language, local language proficiency as required.
Proven clinical experience or management experience in healthcare, clinical research, or contract research organization.
Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials.
Education:
If you are a professional with experience in leading clinical trials and have previously worked as a CRA, as well as holding a solid background in project management or people management, we can offer you a stellar future. A future that will not only involve you in developments of international importance for a renowned sponsor but will also prepare you for project management and other high-level roles.
(Although this role is home-based, please be aware that some occasional travel may be required).
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