Global Clinical Study Manager, Study Start-Up

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center 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.

The **Clinical Study Manager (CSM)** is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CTM leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted accountabilities may or may not apply.

**Provides Project Oversight and Leadership for Clinical Deliverables:**

Leads and manages the start-up and clinical teams

Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.

Works with the team to set priorities

Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters

Motivates the clinical team

Ensures effective communication plans are place for the clinical team

Ensures effective escalation plans are in place for the clinical team

Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study

Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team members

Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues

Identifies opportunities to improve training, execution and quality control across the team

Liaises with relevant staff to provide data as required for clinical operations performance metrics and project status metrics

Works with the relevant staffto identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.

Attends Executive Project Status Reviews as required

**Project Resourcing:**

Works with the relevant staff (including Director of Project Delivery (DPD) when applicable) to ensure all Clinical team members are adequately assigned to the project

Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activities throughout the project duration

Actively monitors initial and ongoing clinical resource and identifies/escalates issues to the Project Manager (PM) and/or Clinical Management when applicable

Liaises with Clinical Operations Managers to resolve clinical resource and performance issues

Disseminates and agrees forecasted activities/FTE to all key team members

Oversees transition plans to allow seamless transition of knowledge in case of CTM member replacement

**Quality - Training & Development:**

Creates and maintains project specific plans, documents and tools for the clinical team.

Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinical project specifics Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies. Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable.

Ensures all PRA project reporting systems are up to date for clinical activities at the project level

Oversees the CSS, GRAL, LRAL and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.

Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.

Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.

Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems

Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines

**Project Finance:**

Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).

Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget

Ensures that forecasted units are achieved as planned and within the budgeted FTE Identifies out-of-scope tasks from clinical team and escalates as required

Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff.

**Customer Relations (Internal & External):**

Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved

Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required

Participates in client meetings, assisting with presentations as required

Contributes to Business Development activities participating in proposals and bid defenses as needed

**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.