Senior Project Manager, FSA

• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our 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. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.

• Attend BID Defence meetings, as directed, to provide strategic study start up advice.

• *Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions

• *Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines.

• *Work with key parties to draft mitigation plans against contractual targets for key milestones

• *Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor.

• *Fully accountable for the implementation of the Study Start Up Plan for all assigned studies

• *Responsible for the Study Start Up element of the Project Communication Plan.
• *Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members
• *In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent “Road Block” situations.
• *Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including:
• Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies
• Accountable for the development, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
• Accountable for the preparation, finalisation and review Master and Country Specific EU Clinical Trial Application Forms (xml file) and corresponding data files in collaboration with other relevant departments (EU Only)
• Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for.
• Accountable for ensuring all submission packages receive an independent quality review prior to submission
• Accountable for co-ordinating the timely negotiation of contracts and budgets with sites
• Accountable for the co-ordination of translations for documents required for submission for assigned studies
• Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system
• Accountable for the timely follow-up for queries made by CA/EC on assigned studies
• Accountable for the collection of critical documents required for IP Release on assigned studies

• *Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan.

• *Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor,
• *Accountable for the timely tracking and reporting for all assigned studies.
• *Accountable for leading the country study start up team members involved in the study. May serve as a mentor and coach for these team members as required.
• *Ensure adherence to the SOW and the site activation budget as per the costing model.
• *Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM.
• *Responsible for the overall quality of the start up phase of the project, address quality issues and ensure implementation of action plans in a timely manner.
• *Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team.
• *Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate
• *Provide regular updates to Study Start Up Management team including production of study metrics
• *Attend all relevant study team meetings throughout the start up phase of all assigned studies
• Ensure effective escalation of issues and feedback including input for Opex (Operational Excellence Meeting) when study is discussed and input into the Global Dashboard for studies in start up
• *Delegate tasks as appropriate to study start up team while retaining accountability for the successful delivery of the study start up plan

• *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs

• To be fully trained in all systems

• Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation.

• *Comply with all department requirements regarding information provision and status updating and reporting.

• To undertake other reasonably related duties as may be assigned from time to time