About the position
The Clinical Trial Study Manager II at Quest Diagnostics is a pivotal role responsible for the coordination and execution of clinical trial projects. This position involves managing the scope, timeline, and budget of assigned projects, ensuring that all aspects of the trials are conducted efficiently and effectively. The Clinical Trial Study Manager will work closely with scientific and technical directors, as well as laboratory operations staff, to develop actionable plans that align with project goals. This role may also include direct line management responsibilities for junior study management team members, along with indirect management of other team members supporting clinical trials. The successful candidate will be tasked with reviewing contracted scopes, budgets, and timelines to create comprehensive plans for project completion. They will maintain client relationships throughout the study, identifying and managing risks that could impact project success. The Clinical Trial Study Manager will also be responsible for maintaining official project records from inception to completion, ensuring compliance with regulatory requirements such as FDA and EMEA standards. Regular communication with customers regarding project updates and scope alignment is essential, as is the ability to adapt to new requests and manage contract modifications as necessary. This full-time position operates Monday through Friday from 8:00 AM to 5:00 PM, offering a competitive salary starting from $88,700 per year, with opportunities for annual performance bonuses and career advancement. The role requires a strong background in healthcare or laboratory settings, along with significant experience in clinical study or project management.
Responsibilities
- Review contracted scope, budget and timeline to develop a plan of action or multiple plans of action to successfully complete project.
- Coordinate with scientific and technical directors as the scientific leaders for the project.
- Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for scope.
- Coordinate with Business Development and Proposal Management throughout the life of the project to ensure scope, timeline and budget are well understood and also understand escalation path for communicating issues.
- Manage and own client relationship throughout the study.
- Identify, track and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.
- Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.
- Maintain official project records from inception to completion including archiving.
- Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).
- Develop overall project plan and maintain regular touch points to ensure that timelines are being met.
- Communicate with customer on regular operational items (project updates, scope alignment).
- Other duties as assigned.
Requirements
- 5 years of healthcare experience or experience working in a laboratory setting
- 3 years of previous clinical study or project management experience required
- Bachelor's Degree in a relevant field
- Excellent verbal and written communication skills
- Exceptional interpersonal skills and business acumen
- Strong organizational skills; very detail oriented and a self-motivated problem solver
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Nice-to-haves
- 3 years of clinical study management preferred
- Previous experience in a GXP environment preferred.
Benefits
- Employee stock purchase plan
- Health insurance
- Dental insurance
- Tuition reimbursement
- Paid time off
- Employee assistance program
- Vision insurance
- 401(k) matching
- Opportunities for advancement
- Annual Bonus Opportunity
- Variable compensation plan (AIP) bonus
- Blueprint for Wellness
- Training provided!
