Senior Clinical Trial Manager

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Clinical Trial Manager as an RBQM Lead to join our diverse and dynamic team. The RBQM Lead will be responsible for supporting the activities of RBQM (Risk Based Quality Management) within ICON, across a wide variety of therapeutic areas, clients and projects. They are responsible for ensuring a robust and high-quality RBQM approach is applied on every assigned study, in accordance with required timelines and with SOPs and ICH-GCP guidelines.

What you will be doing:

• Act as Delegate when assigned on a study.

• Authoring of Quality & Risk Management Plan

• Facilitate - Identification and documentation of CtQ

• Facilitate - Identification and documentation of critical data and processes

• Facilitation of the initial risk assessment process and meetings

• Ensuring on time and high-quality risk assessment completion

• Review critical data path /data flow in association with Clinical data science lead

• Review of critical data review methods in association with Clinical data risk analyst who is the author and owner of Data Review Requirements.

• Input and review of Risk based monitoring strategy- T-SDV/T-SDR, reduced SDV/SDR in collaboration with CTM

• Review/input into QTLs

• Review/input into central monitoring Key risk indicators

• Quality Gate - Review/input into all applicable Functional plans to ensure risk mitigations are appropriately covered.

• Initiate ongoing risk reviews

• Initiate Risk Review Meetings - QRRM

• Quarterly- Operational Quality review checks to ensure-

  Ø Ongoing Risk Review and ensure Risk & Risk control review are documented

  Ø Risk Review Meetings are conducted as planned- with proactive and fully engaged functional leads and sponsor when applicable. Review QRRM slides to identify the adequacy of content in RRM slides.

  Ø Monitoring strategy is operationalized as per plan and in alignment with budget

  Ø Periodic Project Risk assessments as required by changes to critical data or risks or change in milestone or protocol amendments

  Ø Input into division or program-level oversight, quality and compliance processes related to RBQM requirements.

  Ø study level reviews of quality related data, to identify trends and potential risks, including:

• Project non-conformance trending

• CAPA trending (project and site level CAPAs)

• Critical and Major audit & inspection findings (study and site level)

• Present review output to PM and FTLs, collaborating with them on the identification of risks, proposing potential risk mitigations and actions

• Report to Governance and oversight dashboard as per plan

  Serves as a point of escalation for RBQM and/or quality issues for the project team

Your profile:

• Functional expert on ICH E6 and E8

• General knowledge of clinical trials

• RBQM subject matter expert

• Strategic RBM approach knowledge

• Change agent champion

• Experience with RCA and CAPA practices

• Effectively lead cross functional teams

• Strong communication/interpersonal skills

• Ability to influence without authority

• Creative and critical thinker

• Comfortable with challenging the status quo

• Comfortable with ambiguity

• Demonstrate a diversity and inclusion mindset

• Proactively anticipates critical risks/issues and develops contingency plans

• Understands ICON cross functional SOP/WI/workflows and cross-functional roles; translates project concepts into actionable plans

• Promotes knowledge sharing - Effectively mentor’s/Trains Functional leads/study team at all levels to comply with RBQM SOP/ICH GCP E6 & E8

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply