My client is an industry leading and global organisation within the medical diagnostic sector. They are recruiting an exciting role within the Clinical Affairs Team with the responsibility of executing the company's global clinical studies and registries.
The role will be responsible for the planning, implementation, execution and management of clinical research studies.
You will be responsible for executing high quality plans for project/clinical trials whilst also ensuring that budgets and schedule requirements are met throughout the process.
The post holder will be interacting closely with senior leadership across Medical Affairs, R&D, Legal, Finance and Marketing and external stakeholders such as Investigators managing Investigator Led Studies and CROs.
This role will also have up to two direct reports.
* Reporting on study progress with the responsibility of identifying and communicating issues and risks whilst implementing a resolution plan, including managing expectations on unrealistic timelines
* Ensure all trial deliverables are met according to timelines, budget, and resource requirements
* You will be leading the investigator meetings and protocol training meetings and be accountable for all internal clinical meetings related to assigned clinical trials.
* The post holder will be lead the clinical protocol development process: responsible for clinical protocol development, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents; obtain approval from internal review boards.
* Collaborate with the Clinical leadership and investigators to ensure their feedback is adequately integrated into protocol
* Manage all aspects of CRO identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, management of global resources, expertise, and knowledge within the CRO/vendor
* Lead study start-up efforts including study feasibility and site selection
* Collaborate with Legal to create and approve CDAs and CTAs and assure fully executed forms are returned and distributed to appropriate internal parties and maintained in TMF/SMF
* Forecast trial resources needs, including external costs: accountable for the development, management and tracking of trial budget working closely with CRO Management and internal Accounting. Accountable for accuracy of trial information in all trial databases and tracking systems
* Create and maintain clinical project files to internal standards and regulatory requirements and ensure documentation from Investigators meets FDA/GCP/ICH guidelines
* Provide on-boarding and mentoring of new team members as well as guidance, leadership and career development to direct report(s)
* Bachelor's degree or equivalent experience is required
* 7 years global experience as a Clinical Project Manager or relevant work experience
* Experience in diagnostic industry preferred, experience in medical device or pharmaceutical industry will be consideredCompetencies
* Excellent oral and written communication skills
* Strong interpersonal skills with demonstrated successful team leadership and participation
* Strong command of study compliance and local regulations
* Advanced computer proficiency, especially MS Office
* Proven skill in managing and prioritizing multiple tasks simultaneously, with critical attention to detail
* Ability to travel 20 - 40% (domestic and international)
If you would like to apply for this position please email Marcus Jolly, Marcus.Jolly@srgtalent.com