Description
Next-link is looking for a Clinical SME for a REMOTE JOB, who can be anywhere in EUROPE.
Contract duration: 6+ months
Responsibilities:
To manage the deliverables for a given Project through optimum uses of resources, ensuring consistent quality and timeliness of output
(1.) To be responsible for providing technical guidance or solutions
(2.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity
(3.) To ensure process compliance in the assigned module and participate in technical discussions or review.
(4.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.
Manages the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
Works closely with the study team writers to ensure timelines and deliverables are met.
Completes document reviews according to agreed-upon timelines and follows up with the study team writers as needed to meet internal and external timeline commitments and procedural and regulatory requirements.
Updates project-related tracking tools.
Maintains records for all assigned projects, including archiving.
Schedules and conducts document-related meetings, including the preparation of meeting agendas, key data points for discussion, and meeting minutes.
Works closely with the study team to ensure that content and results in clinical documents are accurate and compliant.
Contact: