Regulatory Study Start Up - Contract UK
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Job title: Regulatory Study Start Up
Location: Office-based in either Reading or Edinburgh
Contract length: 6 months
Start date: As soon as possible
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget, and resources
· Oversee the execution of Start Up (including pre-award/bid defence activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines.
- Develop, implement, and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration Start Up (or Maintenance, as applicable).
- Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project specific information.
- May take a lead role in developing long standing relationships with preferred Quintiles customers.
- Deliver presentations/training to clients, colleagues, and professional bodies, as required
- Bachelor's degree in life sciences or related field with 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role; or equivalent combination of education, training, and experience
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities
- Eligible to work in the EU
Please note that this role is on a contract basis in the UK
Key words: regulatory, study, start-up, submissions, CRO, clinical, trials, start, study, regulations, MHRA, FDA, EU, reading, edinburgh, scotland, united kingdom, contract