ICON Clinical Research Manager Clinical Specialist in Limerick, Ireland

The role

The Manager, Clinical Specialist provides management, scientific and clinical oversight for Clinical Trial Subject Matter Experts {CT SMEs) and Content and Functional Reviewers (CFRs).

The Manager, Clinical Specialist will evaluate and provide guidance on new product offerings from Firecrest, as required, to ensure that they are compliant with all regulations using leading edge technologies/processes and meet a true clinical need.

The Manager, Clinical Specialist will provide regulatory expertise to the Firecrest Operations Department on an ongoing basis and ensure that all Operations teams are quality compliant.

  • Responsibilities*

  • As a Manager, the employee is expected to recognize the importance of and create a culture of Process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Travel (approximately 15%) domestic and/or international.

  • Act as Firecrest management representative with sponsors where necessary, including preparing, attending and presenting at sponsor meetings, TCs,etc.

  • Act as a management resource to the company as a whole and particularly to the Firecrest CTSME and CFR teams, including interactions on Firecrest's behalf at a management level with ICON.

  • Provide clinical and scientific input to global product development and business development teams and provide operational expertise in the review of product releases.

  • Support Firecrest Executive Leadership in developing and defining strategic direction and implementing plans to deliver on this.

  • Strengthen clinical knowledge of staff where required and serve as a resource for clinical information to Firecrest staff and initiatives.

  • Advise product development team on features and usability and educate project teams on clinical and scientific rationale.

  • Manage departmental performance against agreed targets and budgets, and within policies and standards ensuring that all projects are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in project implementation.

  • Prepare performance metrics to measure product accuracy; develop and implement strategies to ensure continued success.

  • Provide the planning and management to CTSME and CFR teams by ensuring that appropriate structures, systems, competencies and values are developed and ensures that projects are conducted in accordance with applicable regulatory requirements and guidelines.

  • Ensure that the interfaces between CTSME and CFR teams and other departments are managed optimally.

  • Form informal networks with company management, updating them on a regular basis on developments within CTSME and CFR teams and progress made within each department.

  • Oversee the work of CTSME and CFR teams ensuring that it is of the highest standard; consistent with the agreed approach, in line with the style guide, instructionally effective, and engaging

  • Manage the recruitment of new CTSME and CFRs, the development of competency tests, choosing interviewees, conducting interviews, and selecting successful candidates.

  • Build and motivate a high performing CTSME and CFR teams, by developing and retaining high­ calibre staff to the company in order to continue to meet Firecrest's quality requirements into the future.

  • Provide leadership and direction to CTSME and CFR teams within Firecrest to ensure clinical trial projects are delivered to agreed timescales, cost and quality, and communicate progress to the Firecrest Leadership Team and/or the ICON Business.

  • Coach and develop of direct reports to ensure high engagement and retention of teams.

  • Manage a multi-location team. Ensure that CTSME and CFR teams work with a matrix production team in partnership to optimize project delivery in terms of revenue, quality, cost and timeliness.

  • Requirements*

  • In-depth, proven experience in a Contract Research Organisation or a pharmaceutical or biopharmaceutical company.

  • Strong knowledge of clinical trials, preferably with experience of working with investigator sites.

  • Prior experience at management levels working in and/or leading teams.

  • Ability to lead others in order to move internal teams towards achieving goals that support Firecrest's key strategic accounts.

  • Strong analytical and business acumen skills and strong creativity skills; focused and disciplined.

  • Strong vision and technical leadership, superior strategic planning skills and extensive experience in clinical training.

  • Skilled in interpreting and adapting scientific clinical information for practical training and field application

  • Strong presentation skills; experience speaking publicly and/or presenting to existing or potential clients on topics related to Firecrest.

  • Proven ability to attract, retain, and develop talented direct reports.

  • Experience monitoring and overseeing clinical trial projects.

  • Comfortable working both internally and externally with technical and medical experts providing input into future product strategies.

  • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license.