PURPOSE Direct and manage the delivery of all required start-up, maintenance and regulatory activities for 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. RESPONSIBILITIES
- The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
- Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
- Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
- Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
- Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- 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.
- Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
- Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence. Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up.
- Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
- Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
- May take a proactive role in developing long standing relationships with preferred Quintiles customers.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good negotiating and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
- Good regulatory and/or technical writing skills
- Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Good presentation skills
- Understanding of study financial management
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Potential for frequent travel.
Apply on company website