Clinical Manager (US Regional - Home-based)

Premier Research Group Limited - Portland, OR (30+ days ago)

Our Clinical Managers direct, supervise and support all clinical staff on the project team; liaises with the customer’s clinical team and collaborates with project team members in other functional areas to ensure delivery within contractual obligations and Premier's standards of excellence

The Clinical Manager:
Ensures the effective selection, initiation and motivation of clinical study sites
Plans and drives patient recruitment and retention
Is responsible for ensuring that the clinical team adhere to the appropriate training needs and performance indicators to ensure the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP, protocol and client requirements
Takes the initiative to move the project/program forward and leads in country and global projects where applicable
Is customer focused on both internal and external customers
Leads and manages the clinical start-up and monitoring teams with focus on deliverables
Supports Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
Works with the Project Manager (PM) to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
Plans and conducts initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable
Develops a clinical monitoring plan as well as clinical monitoring tools
Prepares and executes a site and patient recruitment and retention plan
Drives the successful activation of trial sites according to time, quality/scope and budget parameters
Serves as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
Ensures effective communication plans are in place for the clinical team and are actioned
Monitors the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
Escalates issues and provides escalation path for the team
Performs any other duties required to ensure the success of the trial and Premier Research
May serve in a dual CM/PM role on smaller studies

Position requirements include:
Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
Read, write and speak fluent English; and fluent in host country language
Strong experience in clinical trial management as a CM
Experience in managing complex or global trials
Budget/finance experience on a project level and demonstrates a full understanding of project financials