As the primary sponsor liaison and advocate the Clinical Project Manager will plan execute manage and monitor regional single modality or therapeutic area clinical research projects. Utilizing existing templates processes and programs as a guide he or she will adapt/develop implement monitor and be accountable for project protocols operational plans risk management resources project tools/materials documents and timelines. The successful candidate will be managing the day to day activities and performance of a multidisciplinary project team ensuring all decisions align with corporate industry sponsor and regulatory requirements.
Project Management
Manage the planning progress and completion of assigned clinical research projects.
Work with functional experts to ensure all project activities comply with applicable regulations guidelines and corporate policies.
Maintain operational financial and regulatory integrity and safety.
Develop and/or participate in the development of project communications training regulatory submissions and/or audits and selection of third party vendors as required.
Documents and Tools
Manage a crossfunctional team to ensure the appropriate creation delivery maintenance and disposal of all related data documents equipment and tools including protocols SOPs informed consent forms case report forms and instructions.
Prepare investigator updates and other project related reports as required to support the proper conduct and throughout the life cycle of assigned projects.
Project Team Performance
Identify assign and monitor the completion of interdisciplinary project tasks that include site monitoring CRF and database development and revision data collection patient safety/adverse event management document management statistical analysis and/or final report writing and publications.
Ensure task completion performance meets or exceeds quality standards and sponsor/client project and regulatory expectations and guidelines.
Client/Sponsor Support
Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations are appropriately managed by addressing and resolving queries/issues planning and executing all project meetings assisting with site and patient recruitment strategies and materials assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.
Qualifications
Applicants should have a minimum of one to three years of related work experience with ongoing training and a threeyear College Advance Diploma/Degree in a relevant field of study preferable in (Health) Sciences or Clinical Research.
The successful candidate must exhibit the following skills: selfmotivation with strong communication skills and a commitment to achieving positive results.
Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
Ability to engage in continuous learning and selfdevelopment.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.