Description
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Key responsibilities include:
- Overseeing the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Developing, implementing and maintaining the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensuring collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Creating and/or reviewing technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Providing specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Providing 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.
- Determining regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identifying regulatory complexity and challenges and offering creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assessing and reviewing the regulatory landscape and contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Executing operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Working with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- Mentoring and coaching colleagues as required.
- Ensuring accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
- Taking a lead role in developing long standing relationships with preferred IQVIA customers.
- Delivering presentations/training to clients, colleagues and professional bodies, as required.
- Being involved in activities related to monthly study budget planning and reviews.
The successful candidate will have:
- A Bachelor's Degree in Life sciences or related field.
- 7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
- 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.