Associate Regulatory & Start Up Director
Closing Date: 18 Feb 17
Type: Full Time
Salary (£): Negotiable
PURPOSE Direct and manage the delivery of all required start-up, maintenance and regulatory activities for multi-protocol programs and global mega trials 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. May also be required to undertake specific customer responsibilities. ...
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for multi-protocol programs and global mega trials 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. May also be required to undertake specific customer responsibilities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Oversee the execution of Start Up (including pre-award/bid defense 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 and cross-functional 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; coaching members of the team to ensure timely delivery of projects.
- 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.
- Oversee and 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 of Start Up (or Maintenance, as applicable).
- Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
- 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 and initiate cross functional issue resolution to meet customer needs adapting Quintiles processes.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- Serve as liaison for non-specific projects for key customers.
- Excellent 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 and programs.
- 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
- Excellent regulatory and/or technical writing skills
- In-depth knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
- Excellent leadership skills, with ability to motivate, coach and mentor
- Excellent organizational and planning skills
- Proven ability to exercise independent judgment taking calculated risks when making decisions
- Excellent presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors
- Strong financial acumen
- Proven ability to work on multiple projects balancing competing priorities
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field with 10 years’ relevant experience including at least 3 years in a lead position within Study start or execution and demonstrable experience in an international 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.
- Frequent Travel may be required.