Piedmont Healthcare
Country Study Operations Manage
Canada, Burlington
Sponsorship not specifiedDetected 6 days ago
TypeScriptProject ManagementStakeholder ManagementAccount ManagementValuationCAMVoIPClinical TrialsClinical ResearchResearchCommunicationCollaborationProblem SolvingPublic SpeakingGxP
About the role
- As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.
- Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.
- Votre rôle consistera à superviser tous les aspects de l'exécution du projet, de la planification et de la gestion des ressources à la communication avec les parties prenantes et à la gestion des risques.
Responsibilities
- Provides protocol level guidance and support to responsible Local Study Team members as applicable.
- Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
- Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
- May lead operational effectiveness initiatives at country or regional level
- Responsible for PTA and SIV report review for reports completed by the Site Care Partner
- Supports implementation of client's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
- Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
- Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
- Support Identification, contract development and management of local vendors or facilities as per protocol
- Investigator Meeting support and management including doing presentations as appropriate
Requirements
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
- BS/BSc/MS/MSc degree required
- BA/BS 5+ years of relevant experience operational clinical trial experience
- MBA/MS/ 3+ years of relevant experience operational clinical trial experience
- Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
- Demonstrated experience in managing country level operational activities and/or vendors
- Experience in Study and Quality management and working in a matrix management environment
- Expertise in the use of study/site dashboard and reporting tools
- Detail oriented & possesses technical expertise
- Ability to operate in a matrix environment
Nice to have
- A scientific or technical degree is preferred along with knowledge of clinical trial methodology
Benefits
- Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
Company info
- Country Study Operations Manager
- ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
- As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
- We are currently seeking a Project Manager to join our diverse and dynamic team.
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This listing is sourced directly from Piedmont Healthcare's careers page and normalized into a canonical job model.