Clinical Research ociate Project Manager - 8351

Position : Clinical Research ociate (CRA)/Project Manager (PM)

Working Hours : Core work hours :9 AM 5 PM PST ( Additional availability may be required for meetings outside regular hours due to USbased management. Note: The client will determine and adjust working hours as needed.

Salary Range : USD (the final salary will be determined by the candidate's level of experience and at the discretion of the client)


ABOUT THE COMPANY:
The organization operates within a dynamic international environment dedicated to advancing clinical research. We foster a collaborative atmosphere where flexibility and adaptability are crucial to engaging effectively with team members and clients worldwide.

ABOUT THE ROLE:
Our client is seeking a highly motivated and experienced Clinical Research ociate (CRA) / Project Manager (PM) to lead and manage clinical research projects. The ideal candidate will possess a robust background in clinical research and project management capable of handling complex projects and leading diverse teams effectively.

SCOPE OF WORK:

Project Management:

• Lead clinical research projects.
• Design project workflows and charters.
• Setup projects on OIRRC systems.
• Develop and maintain project schedules set targets and ensure accountability.
• Lead internal and client meetings prepare agendas and approve minutes.

Team Leadership (for leadership positions):

• Supervise and guide CRAs/PMs.
• ist with recruitment.
• Develop and administer training modules.
• Mentor junior staff including hiring and performance evaluations.

Clinical Research:

• Conduct and manage complex research projects.
• Oversee large studies or manage smaller studies across multiple sites.
• Develop systems for data management.

Compliance and Quality urance:

• Adhere to organizational policies and procedures.
• Ensure audit preparedness and regulatory compliance.
• Implement corrective actions and processes.
• Inspect study doents for compliance.

Communication and Collaboration:

• Attend relevant meetings with sponsors vendors and contractors.
• Be available for emergency calls during offhours.
• Recommend and implement policy improvements.
• Collaborate with crossfunctional teams.

Financial Management:

• Track study milestones and invoice sponsors as per contracts.

Performance Evaluation:

• ist in appraising and reviewing the Clinical Operations team's performance.

Continuing Education and Knowledge Sharing:

• Participate in continuing education and training.
• Prepare presentations on scholarly articles.
• Attend virtual conferences and share insights.
• Contribute to team knowledge sharing.

REQUIREMENTS and QUALIFICATIONS:

• Fluency in English.
• Minimum of two years’ project management experience in healthcare.
• Completion of required OIRRC qualifications and training.
• CCRP certification or equivalent within six months of start date.
• Strong team management and project management abilities.
• Proficiency in clinical research odologies and regulatory requirements.
• Ability to manage complex schedules and budgets.
• Independent and teamoriented work capabilities.
• Ability to meet strict deadlines and handle stressful situations.
• Effective delegation and escalation ss.

BONUS SS:

• Ophthalmology Experience Strongly Desired
• Study Coordinator Site Experience
• Photographer Site Experience
• Heidelberg Spectralis
• OptoVue AngioVue
• Zeiss Cirrus
• Any standard color fundus camera with 30–60degree lens
• Optos
• MAIA Microperimetry
• Nidek MP1 or MP3