Project Manager - Medical Affairs

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

This Project Manager - Medical Affairs is a role where you will be responsible for NIS studies, Low -Interventional studies and Pragmatic clinical trials. 

This is a Project Manger role supervising CROs and vendors, controlling budget, responsible of writing ICD, some manuals and reviewing CRO manuals (and CRF),  study templates design, responsible of the TMF, CRO selection and updating the study data.

The Project Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release.

The Project Manager provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution.  The Project Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Project Managers may also input to and support compilation of sections to Clinical Study Reports The Study Manager will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.

The Project Manager is a core member of the Study Team and will represent the CRO on matters of study execution.

The Project Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues.  The Study Manager will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.

For studies where more than 1 Project Manager is assigned may be required to act as ‘lead’ study manager and will coordinate activities of the other Study Managers assigned.

ROLE RESPONSIBILITIES

Responsible for Study Management and oversight of all Study Management functions internally and at the CROs

Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies

• Accountable for the development of realistic detailed study startup and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
• Leads study risk planning process in context of site and subject
• Coordinates study/protocol training & investigator meetings
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Accountable for the delivery of the study against approved plans
• Leads inspection readiness activities related to study management and site readiness
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

Study Management Oversight

• Approves the Study Startup, Study Monitoring & protocol recruitment plans
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Voice Randomisation System with Supply Chain Lead
  • Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
• May support study level submission readiness

Study Team Interface

• Leads and oversees all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
  • Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
• Shares and escalates plan deviations to Clinical Project Manager (and study team)
• Provides ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol design

Subject Matter Expertise

• The Study Manager will be the technical expert for study management systems and processes
• The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
• The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to:  mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
• The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.

For project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection.

Training and Education Preferred:

• Extensive global clinical trial/study management experience
• Medical Affairs experience
• Experience in late phase clinical trials
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• BS/Nurse – minimum of 5 years relevant experience
• MS/PhD – minimum of 3 years relevant experience

Prior Experience Preferred:

• Experience in non-interventional studies
• Demonstrated study management / leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend

Skills:

• Understands how to work with vendors to accomplish tasks
• Ability to interpret study level data & translate and identify risks
• Ability to proactively identify & mitigate risks around site level in study execution
• Understands feasibility of protocol implementation
• Country level cultural awareness and strong interpersonal skills
• Keen problem solving skills
• Excellent communication skills, both written and verbal. Must be fluent in English.

Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.