ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As Clinical Project Manager, will be dedicated to one of our global Biotechnology clients who pride themselves on their quality and patient centric approach. They continue to challenge the status quo whilst ensuring the highest standards of compliance and acknowledging the importance of both global and local expertise.
Provides Project Oversight & Leadership for Clinical Deliverables:
· Leads and manages the start-up and clinical teams.
· Plans and leads execution of day-to-day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates.
· Vendor management and budget management, if required
· Works with the team to set priorities.
· Leads and supports the relevant staff (ie, local start-up staff, local and global regulatory affairs staff, in-house clinical staff, etc) to drive successful activation of trial sites.
· Motivates the clinical team.
· Ensures effective communication and escalation plans are place for the clinical team.
· Facilitates cross-functional team communication for proactive, study-wide problem solving regarding study progress and trial issues during the study.
· Monitors the quality of clinical activities and addresses quality issues with the appropriate team member.
· Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues.
· Identifies opportunities to improve training, execution, and quality control across the team.
· Liaises with relevant staff to provide data, as required, for clinical operations performance metrics and project status metrics.
· Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
Quality – Training & Development:
· Creates and maintains project-specific plans, documents, and tools for the clinical team.
· Plans, oversees, and conducts initial and ongoing training for the relevant study staff on clinical project specifics.
· Analyzes data related to sites activation, monitoring, data retrieval, and close out to identify issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks; communicates risks and mitigation strategies.
· Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues, as applicable.
· Ensures all project reporting systems are up to date for clinical activities at the project level.
· Oversees the relevant start-up, regulatory, and in-house clinical staff to ensure all initial or amended trial information is submitted, approved, and filed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
· Oversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
· Identifies metrics and trends across team members, countries, regions, and uses the information to promote improvement in quality and consistency of execution.
· Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventive action (CAPA) plans, responds completely and accurately to audit reports, and provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses.
· Organizes project-specific compliance plans for key processes, tools, and systems.
· Reviews filing of Essential Documents in the electronic Trial Master File (eTMF) to ensure sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH guidelines.
Project Team Relations:
· Interfaces with relevant team members and vendors as required to ensure clinical monitoring outcomes are achieved.
· Serves as primary liaison for clinical monitoring issues, interacting with relevant team members and vendors and escalating as required.
· Participates in team meetings, assisting with presentations as required
- Medical Doctor; relevant specialty education preferred (e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatrics).
- Experience in industry in a Lead or Manager role.
- Excellent English, both written and spoken is a must, as well as ability to travel.
- Proven interpersonal skills enabling to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately.
- Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization.
- Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action.