Performs assigned activities within the SSU Central Services Life CycleMaintenance Team that support SSU activities as needed, for studies which havecompleted activation, in all phases of clinical trials related toinvestigational drugs, biologicals and medical devices as required.
Provides oversight of all project SSU activitieswhich encompasses all activities for life cycle maintenance amendmentdeliverables.
Collaborates with all major functional arealeads including (SSU Country Managers, Project Management, Clinical, DataManagement and Medical Writing).
Ensures all project deliverables meet theinternal customers’ expectations and the contracted deliverables and any keyperformance indicators, providing accurate projections, quality of output,reports and updates, and ongoing risk assessments, as per manager’sinstruction.
Develops and maintains relationships withcustomers in alignment with their assigned projects. Ensures that individualproject targets and client needs are met, services are provided with thehighest quality standards, and policies and procedures are followed.
Assumes accountability on SSU deliverablesincluding, but not limited to :
oLife cycle maintenance amendment activities;
oCommunication and coordination with countrystart-up specialists for allRA, IEC / IRBsubmission deliverables;
oOverall SSU timelines for life cycle maintenanceamendment activities;
oCommunication and coordination with SiteContract Negotiator(s) for amendments to contracts and / or budget independent tothe submission deliverables.
Maintains plans in accordance with StandardOperating Procedures and / or sponsor-scoped processes.Complies all controlled document requirementsand other requirements to ensure quality deliverables.
Manages life cycle maintenance activities’timelines and reports weekly progress including plans to address any potentialtiming risks / gaps and prepares and presents regulatory strategy and status atclient meetings and communicates outcomes to project team.
Reviews the project budget for out of scopeactivities for life cycle maintenance activities in collaboration with Project Lead(PL) to ensure project profitability.
In collaboration with the PL, reconciles revenueunits completed and projects future units on a monthly basis
Uses corporate tools for planning and managementof scope, timeline, and resources and ensures minimum hours are used fortasks.
If out-of-scope work isrequested, notifies the PM and tracks out-of-scope work.
Prepares the core submission documents and coreclinical trial application dossier and obtains agreement from the Sponsor onpackage contents in line with the Regulatory Impact Assessment.
Performs a Regulatory Impact Assessment on coreamendment submission documents and communicates any risk mitigation toSponsor / Project teams and oversees review for Regulatory Impact Assessment for2nd level to identify gaps, highlights any risk management to Sponsor / Projectteams
Oversees country compilation, quality review,and submission of country-specific applications as per the study’s scope ofwork and Integrated Site Activation and Maintenance Plan.
Accountable for the timely follow-up for EthicsCommittee / Regulatory Authority enquiries or objections in collaboration withthe country SSU Specialists.
Meets orexpedites the planned submission / approval timelines; if forecasted timelinesare not reached or if any potential issue is identified, pro-actively solves orescalates the problem quickly.
Identifies best practices and participates inprocess improvement initiatives in conjunction with the global SSU leadershipplan and project deliverables.
Provides life cycle maintenance specifictraining and mentoring to junior teams and / or new starters.
Provides oversight supporting SSU &Regulatory Director with quality issues and escalations as required supportingSSU business unit requirements.
Attends Sponsor meetings to discuss regulatorystrategy for complex study amendments or changes supporting other more juniorteam members.
Attends and provides SSU operational oversightpresentations for audits or inspections as required.
QUALIFICATION & REQUIREMENTS
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
Good understanding clinical protocols and associated study specifications
Excellent understanding of clinical trial start-up processes
Project management experience in a fast-paced environment
Good vendor management skills
Strong organizational skills with proven ability to handle multiple projects
Excellent communication, presentation and interpersonal skills
Quality-driven in all managed activities
Strong negotiating skills. Strong problem-solving skills
Ability to mentor, lead and motivate more junior staff
Demonstrate an ability to provide quality feedback and guidance to peers
Contribute to a training and Quality assurance plan within SSU and update SOPs / WI