Sr. Clinical Process Associate
Quintiles Research India Pvt Ltd
Job Description
Description
PURPOSE
Provide project related assistance for assigned complex 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.
RESPONSIBILITIES
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
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Participate in document management (creation, review, maintenance, storage, as applicable)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws,
regulations and guidelines
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
Attention to detail and accuracy in work
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel
and PowerPoint
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Proven ability to work on multiple projects balancing competing priorities
Ability to coach/ mentor junior colleagues
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and min 2 years relevant experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require working in shifts.
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