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Clinical Project Manager (Non-MD) - C

Santa Clara, CA 95054

Posted: 08/16/2024 Employment Type: Contract Job Category: Project Management Job Number: 613963 Is job remote?: No Country: United States

Job Description


Working with diverse groups such as Regulatory Affairs, Program Management, Research & Development, Quality Assurance and external clinical contractors the primary role of this position is the facilitation and management of our Clinical Study program.

This positions responsibilities include, but are not limited to:

•    Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
•    Oversees development of clinical documents, including clinical plans, protocols, forms, and reports.
•    Manages team to prepare for clinical study initiation, execution and close out activities.
•    Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop.
•    Communicates and works with cross-functional teams to resolve issues that arise during clinical studies.
•    Ensures consistency of clinical study and processes across clinical trials.
•    Travels as necessary to aid in program facilitation.


The position requires excellent communication skills, the ability to prioritize and work independently. Exposure to basic Project Management methods, knowledge of statistics would be an advantage as well as experience using the APOC i-STAT or equivalent system.


Qualifications
To be considered for this position, you will have the following education, skills, and abilities:

•    Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent. 
•    5+ years experience in managing clinical studies or equivalent product development programs.  Experience in in vitro diagnostic/medical device related studies is an asset.
•    Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices is desirable.
•    Advanced skills in project planning and management, judgment, decision-making, and problem solving. 
•    Working knowledge of new product development methodologies an asset. 
•    Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements and internal policies

 




Pay Rate Range: $50-65/hr. Salary will be commensurate with experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.