CLINICAL PROJECT MANAGER II - Remote
Location: Carlsbad, California
Job Type: Full time
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
The Clinical Project Manager will manage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.
- Manage the full scope of Clinical Studies including, but not limited to timeline, budget, and project milestones
- Lead and support cross-functional study teams and facilitate team meetings as needed to move clinical activities forward
- Serve as the main contact and liaison for Client to provide weekly updates
- Track and report progress of sites including subject screening/enrollment, data collection, and identify study-related issues, confirm resolution, and ensure proper documentation through Toolbox Event system.
- Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Research and learn project indication
- Generate clinical study documents such as Protocols, ICFs, Source Documents, Site Operation Manuals, and Monitoring Plans and ensure the maintenance of essential documents in TMF including transfer to Client.
- Review and verify accuracy of clinical trial data collected, either onsite or remotely. Provide regular site status information to team members, trial management, and update trial management tools
- Ensure completion of monitoring activity documents as required by Toolbox SOPs or other contractual obligations.
- Perform essential document and Trial Master File reconciliation. Perform source document verification and query resolution
- Work with the CRAs assigned to the project to ensure SIVs, IMVs and SCVs are scheduled appropriately. Review and approve CRA reports.
- Work the Clinical Project Coordinator on start-up activities including site contracts and budget negotiation.
- Work with Data Management in the query resolution and validation process and ensuring timely database lock.
- Work with Clinical Supplies in the management of Investigational Product (IP) and ancillary supplies.
- Assess IP accountability, dispensation, and compliance at the investigative sites.
- Ensure all required project-related training is completed and documented
- May be assigned additional Clinical Operations tasks
- Help create a fun, rewarding and collaborative environment
What your background should look like:
- Bachelor’s degree; advanced degree (Master’s or above) preferred
- Certification CCRP or CCRA is a plus but not required
- Extensive experience (5+ years) as a CRA including the ability to interact effectively with investigators and cross-functional teams; in vitro diagnostics experience is preferred
- Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements
- Strong work ethic and demonstrated ability to deliver assignments on time
- Ability to travel (up to 80%)
- Ability to handle difficult situations professionally and maintain a professional and caring demeanor
- Proven ability to collaborate in a team environment and work independently
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Must be responsible, creative and highly motivated
Works Closely With:
VP of Clinical Operations, Director of Clinical Programs, Manager of Clinical Operations, Clinical Project Coordinators, CRA’s, and CTA’s
ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
- Competitive base salary commensurate with experience: $83,700 - $125,500 (subject to change dependent on physical location)
- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
- Total Compensation = Base Salary + Incentive(s) + Benefits
- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
EOE, Including Disability/Vets