Clinical Site Associate 1

1 week ago

Thane, India IQVIA Full time

Job Overview
Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions
- Perform processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Task may be assigned on either Start-Up studies or Maintainance studies.
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Review, evaluate and recommend modifications to designated processes
- Participate in document management (creation, review, maintenance, storage, as applicable)
- Participate in (study) team meetings and implement action items
- Collaborate with the project lead/team members in creation/review of study documents
- Setting quality standards and reviewing deliverables to the same for process tasks.
- Work on visit tracking in CTMS for Investigator payments, Vendor Setup QC’s, PV Batch Review, Passthrough invoice Batch Review & associated tasks.
- Providing and revoking access.
- Review ATP (Authorization to proceed) trainings.
- Cordinating with translation vendors.
- Understanding the contracts & enabling excellent output quality for the processing teams.
- Ensure effective and efficient coordination between the operations team (PM/RSU/Clinical/IPA) for visit/passthrough batch query resolutions.
- Ability to work in a deadline orientated environment and manage SLA’s (TAT, Productivity, Quality) effectively.
- Respond to ad-hoc requests for data/information/analysis.
- Responsibile for general administrative support for projects, tracking various kinds of activities.
- Responsible for indexing.
- May act as a buddy for new Hires and SME for the team

**Qualifications**:

- Life Sciences graduates with minimum 2 years relevant experience.

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