Ref #: 28365

Employment type: Permanent - Full-Time

Location: China

Posted: 13-Apr-2021

Description

Lead study teams in management of CROs for IDM process; including (input to) the development of pharmacy related materials (e.g, forms and manuals) and system set-up (e.g, IVRS and EDC).
Resolve and document urgent/critical unblinded and pharmacy related issues and investigate trends (IDM)
Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans
Ensure adherence to timelines and quality of the IDM process and follow up with vendors appropriately to resolve any issues
Act as the main point of contact for resolution of any ad-hoc questions associated with IDM issues
Provide input to refine GCO IDM process in alignment with stakeholder needs and in compliance with systems, and strategies by identifying innovative process improvements, determining feasibility, and collaborating with appropriate parties to implement when appropriate
Work proactively to increase global awareness of IDM processes and train and educate stakeholders
Work closely with stakeholders that are globally located ? Contribute to ensuring optimum utilization of resources and compliance with project deadlines for IDM
Oversees all (Lead) IDM activities ? Reviews IDM monitoring visit reports (initiation, periodic & close-out) (defined %)
Monitors status and resolution of major/critical issues via Issue logs and visit report review process
Translates, documents and escalates major/critical issues to GTM and the trial’s medical monitor in a blinded manner
Provide inputs in audit CAPAs
Assist in database locks in reviewing un-blinded queries (if needed)
Provides updates to GTM on pharmacy-related and compliance issues in a blinded fashion
Ensures training is provided to the (Lead) IDMs and staff involved in the management of TTs.
Potential of Co-monitoring of IDMs and Lead IDM
Potential for Management of day-to-day operational support of IDM
Version 24102014 Approved by Director Global Program Management
Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCO management as well as R&D companies, corporate, HCC and QA guidelines
This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.

Requirements:
Candidate is required to have at least 3-5 years of experience in clinical trial operations.
Fluency in English.
Must demonstrate the ability to solve complex issues.
Experience in project management and/or logistics is mandatory.
Must demonstrate innovative spirit, strong interpersonal and leadership skills and complex project management.
Knowledge of databases and/or project management systems is also a plus.
Previous work in an international environment desirable.