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Job Details

Clinical Project Director

Company: RBW Consulting
Location:
Reference: SI-CPD-001
Closing Date: 23 Dec 16
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

I am currently working on a new fantastic opportunity for my client who is looking for a project director. If you are looking to work for a niche CRO who value your work and quality over quantity then make yourself known and get in touch!

Requirements:

This company is a new formed small boutique CRO that work very differently to the standard ‘Global’ CRO even with an international presence they very much look at work in a different way, they focus on quality of the projects rather than the quantity, thus leading them the win studies and projects over the usual CROs. This is an ideal company for someone who feels over worked and undervalued!

You will have full project management responsibility, working on complex or non-complex studies with any number or countries and centres.

This role will be fully office based in the Berkshire area.

Candidate profile must have:

  • 8 years experience or more working within clinical operations, data management within a commercial setting.
  • 4 years of project management experience within Clinical
  • Life Science/ Healthcare degree or equivalent to

Your responsibilities will be/ but not limited to:

  • Acts as the primary point-of-contact and liaison with the Sponsor to provide outstanding customer service and serves as an ambassador to promote ORION's high quality and ethical image;
  • Leads the study team with the goal to contribute towards efficient management of trials;
  • Acts as the primary point-of-contact and liaison with any 3rd party vendors, as per the ORION-Sponsor scope of work;
  • Develops and maintains good working relationship with Investigators and study staff, as appropriate;
  • Performs risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner, ensuring that the Sponsor is kept fully informed of potential risks and issues in a timely fashion;
  • Communicates effectively with both site personnel and ORION management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues;
  • Mentors, trains, and supervises ORION study team at a functional level;
  • Organises study handover meeting with the study team once handover from Business Development department has occurred;
  • Performs detailed project planning and forecasting to ensure all relevant steps required for the set up, conduct and close out phases of the clinical trial are performed in the timelines agreed with the Sponsor, to budget, and with a high quality;
  • Designs and develops clinical trial documents such as study plans, site manuals, and subject information/consent;
  • Oversees submissions to regulatory authorities and Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions (in collaboration with the Regulatory Affairs and Technical Writing department) including overseeing collection of essential (regulatory) documents from sites and Sponsor, organising translations of study related documentation;
  • Ensures third party vendors (such as central laboratory, investigational medicinal product (IMP) packaging/distribution, interactive voice response system (IVRS) are organised according to the study's needs and as per the ORION-Sponsor scope of work.

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be. Please contact Sayful Islam on +44 (O)1293 584 300 or email a CV to sayful.islam@rbwconsulting .com.

Clinical research associate | CRA | CRA II | SCRA | senior clinical research associate | monitoring | clinical trials | clinical research | Oncology | Respiratory | Cardiovascular | regional travel | pharma | pharmaceutical | trials | clinical research | single sponsor | South England | South East | South West

Apply for this job: Clinical Project Director

Contact Information:

Address:  Brighton
Southdown House, 130a Western Road, Brighton BN1 2LA
BN1 2LA
England
Tel:  01293 584 300

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