Ref #: 27126

Employment type: Permanent - Full-Time

Location: US - Home-Based - East Coast

Posted: 23-Feb-2021

Description

• Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
• Accountable for the oversight of IST/ISS granted by the sponsor, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
• Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
• Develop and monitor study budget and timelines
• Monitor work to ensure quality
• Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
Contribute to the planning and set-up of a study and provide planning parameters , Support early access programs on the country level

Description needs to cover the main tasks/ core activities of the job, geographical aspects, business expertise, problem solving, complexity of tasks and problems/ innovative solutions Understanding of local / country requirements for clinical trials
• Managing and steering CROs
• Networking skills to represent the sponsor with key local stakeholders
• Proactive issue monitoring and management

Financial Dimension:
• Manages the budget for all local clinical studies and Global Phase IV studies assigned, as well as the IST/ISS
grants.

Strategic Impact:
• Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials, as well as the IST/ISS grants.
• Support local organization in delivering local medical strategy across the portfolio within own country
• Work with CRO in county to ensure local trials are delivered within desired quality, timelines, and costs

Scope of People Responsibility:
• Management of People
• Overseeing external providers.
• Act as an interface between Global Clinical Operations and local organizations (Global Operations)

Cooperation:
Describes if communication is mainly focused on internal or external contacts
Internally
• Country organization
• Medical Affairs (HQ and country)
• Financial planning and analysis
• Local and Global Drug Safety
• Other global functions incl. Biostats, Data Management, Medical Writing, etc
• Service Provider Management (SPM)
• Legal
• Finance

Externally
• CROs and other service providers
• Medical experts/Key Thought Leaders
• Investigators and clinical site personnel
• Representatives of institutions/hospitals


Necessary professional experience
• At least 3 years of experience in clinical research in a CRO, pharma or biotech company
• Experience in clinical trial planning and conduct
• Thorough knowledge of ICH GCP and applicable local regulations