What are the responsibilities and job description for the Senior Clinical Project Manager position at KlinEra Global Services Inc?
The Senior Clinical Project Manager (Sr. CPM) is responsible for overseeing and managing clinical trials from initiation through to completion. This role ensures that clinical projects are executed in compliance with regulatory requirements, within budget, and on time.
Qualifications :
Bachelor's degree in life science / related field, advanced degree preferred
Minimum of 5 years of experience in clinical project management, with at least 3 years in a leadership or senior role
Proven experience as a clinical project manager or similar role in the pharmaceutical, biotechnology, or medical device industry
In-depth knowledge of clinical research, FDA regulations, and ICH / GCP guidelines
Excellent organizational and time-management skills with the ability to manage multiple projects simultaneously
Superior communication and interpersonal skills, with a proven ability to collaborate with diverse teams and stakeholders
Proficiency in project management software and clinical trial management systems
Ability to travel domestically and internationally
Responsibilities :
Lead and manage all phases of clinical trials, including planning, execution, monitoring, and close-out
Develop detailed project plans, timelines, and budgets
Oversee and coordinate cross-functional teams, including clinical research associates (CRAs), data managers, biostatisticians, and other team members. Provide leadership and mentorship to junior staff
Able to motivate a team to work effectively in a changing and fast-paced environment
Ensure trials comply with Good Clinical Practice (GCP), regulatory requirements, and company policies
Prepare and review regulatory documents and submissions
Act as the main point of contact for internal and external stakeholders. Communicate project status, issues, and milestones effectively
Identify potential risks and develop mitigation strategies. Address issues proactively to ensure project goals are achieved
Develop, track, and manage project budgets. Allocate resources effectively and ensure financial oversight
Organize and run assigned clinical study team meetings and teleconferences
Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
Escalate pertinent CRA performance and site compliance issues when necessary
Ensure accurate and timely collection, analysis, and reporting of clinical trial data. Maintain data integrity and compliance throughout the trial
Monitor and ensure adherence to protocol and quality standards
What We Offer :
Competitive salary
Opportunity to work on cutting-edge projects and make a significant impact
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