• Initiation Clinical Site Manager I Jobs in United Kingdom - 25364492

  • PAREXEL International Ltd
  • United Kingdom, Uk
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Parexel is in the business of improving the worlds health We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability

We are currently hiring an experienced Study Start up Specialist for our Uxbridge office Candidates must have strong previous study start up experience working in the CRO industry Please apply below if you are interested and have the relevant SSU experience

This role will be based at our UK Head Office situated in Uxbridge This is close to both Uxbridge train station as well as the town centre and the building has plenty of free parking

The Initiation Clinical Site Manager II, will specialise in Pre SIV activities will be assigned and accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study The iCSM II can also support protocol amendments if applicable

Your Key Accountabilities

Start-Up (from site identification through pre-initiation)
- Act as Parexels direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
- Build relationships with investigators and site staff
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments
- Conduct remote Qualification Visits (QVs)
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments
- Prepare and submit IRB/IEC application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
- Forecast, develop, manage, and revise plans and strategies for
- IRB/IEC submission/approval,
- Site activation,
- Patient recruitment & retention
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections
- Work in a self-driven capacity, with limited need for oversight
- Proactively keep manager informed about work progress and any issues Qualifications Education
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

- Strong problem solving skills
- Able to take initiative and work independently, and to proactively seek guidance when necessary
- Excellent presentation skills
- Client focused approach to work
- Ability to interact professionally within a client organization
- Flexible attitude with respect to work assignments and new learning
- Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise
- Strong ability to make appropriate decisions in ambiguous situations
- Willingness to work in a matrix environment and to value the importance of teamwork
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
- Excellent interpersonal, verbal, and written communication skills
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables
- Excellent time management in order to meet study needs, team objectives, and department goals
- Proven ability to work across cultures
- Shows commitment to and performs consistently high quality work
- Ability to successfully work in a (virtual) team environment
- Consulting Skills
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned
- Act as a mentor and role model for other team members
- Effectively enlist the support of team members in meeting goals
- Attention to detail

Knowledge and Experience
- Intermediate level study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology
- Strong previous Clinical Site Agreement (CSA) and site contracts experience is desirable for both new and exisitng study amendments

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry Your hard work will be rewarded with a competitive base salary as well as a benefits package including 25 days holiday per year, strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading edge benefits that you would expect with a company of this type

If you are ready to join Parexels Journey, please apply!

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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