Senior Study Manager

May lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following:

• Operational point of contact for trial execution and all trial deliverables

• Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning

• Manages deployment and interactions with external vendors (e.g., IVRS, PRO)

• Initiates planning for Investigator meeting and protocol training.

• Plans and assesses protocol ancillary supplies

• Completes trial set-up and maintains CTMS

• Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT

• Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries)

• Oversees protocol training activities including IMs and CRAs training meetings

• Ensures appropriate postings to investigative site portals

• Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)

• Point of escalation for study related operational issues

• Responsible for operational details at Operational Reviews

• Responsible for creating and maintaining project schedule and collaborating with Program Lead

• Sets up and maintains Trial Master File (eTMF)

• Ensures alignment of budget with protocol needs

• Responsible for executing protocol within the budget

• Responsible for creating and maintaining ADI logs

• Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

• Develops study related manuals (e.g., administrative binder, lab manuals)

• Manages Emergency Unblinding (EUB) Call Center activities

• Co-authors newsletters with CS

• Approves contracts, invoice payments and change orders for vendors, as necessary

• Responsible for end of study reconciliation (clinical & ancillary supplies)

• Oversees all HQ close-out tasks

• Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking

• Supports CS activities as needed to achieve CTT deliverables

• Interface with External Data Coordination and Data Management

• Responsible for quality control and inspection readiness at all times

• Responsible for risk assessment, mitigation planning and execution

What you need to have:

• BS/BA/MS/PhD with 7+ yrs clinical research experience Minimum Years of Experience

• Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.

• Proven ability to meet aggressive timelines

• MS Project experience preferred

• Excellent Excel and PP skills required

• TA- Infectious disease and/or vaccines experience highly preferred

• Global experience required

• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

• Home Based position in US or Canada

Areas of direct experience:

• Protocol design for pragmatic trials

• Site/site network selection

• Integration with healthcare systems

• Informed consent approaches (simplified, eConsent, etc.)

• Use of EHR / real-world data

• Endpoint definition (e.g., hospitalization, utilization)

• Central vs site monitoring approaches

• Vendor/technology integration

• Regulatory interactions / submissions

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our to read more about the benefits ICON offers.