Clin Process Spec 2

3 days ago

Thane, India IQVIA Full time

Job Overview

Essential Functions
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents/ trackers
- 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
- Oversee and 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 including Quality manuals
- Act as point of contact for assigned deliverables for specific customers or projects/Stakeholdrs
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalate quality issues to relevant stakeholders and/or line manager.
- Coach junior clinical process associate/specialists
- Approve the site visit reports with applicable protocal knowledge, within applicable timelines.
- Act as a SME for new Joiners and the team.
- Design training content for on processes for the team.

**Qualifications**:

- Bachelor's Degree Life Sciences Req
- Typically requires 5-6 years of prior relevant experience.
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related
- systems and software’s utilized in clinical operations.
- Strong written and verbal communication skills including good command of English language
- Results and detail-oriented approach to work delivery and output
- Good problem solving skills
- Good planning, time management and prioritization skills
- Ability to handle conflicting priorities
- Attention to detail and accuracy in work
- and PowerPoint
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Strong leadership skills
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
- Act as a mentor for Clinical Process Associate colleagues

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