Provide project related assistance for assigned complex project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. 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
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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good knowledge of, and skill in applying 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
Ability to handle conflicting priorities
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
Good leadership skills
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
Setting quality standards and reviewing deliverables to the same for process tasks.
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