Regulatory & Start-Up Lead
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.
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
- Good interpersonal skills, a strong team player
- Experience in regulatory and/or technical writing
- Good understanding of regulated clinical trial environment and knowledge of drug development process
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- 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
- Good understanding of study financial management
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in life sciences or related field, with 3 years’ relevant experience including demonstrable experience in a regional role or equivalent combination of education, training and experience.
- 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.
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