Upsilon Global

Clinical Trial Manager - Medical Device

Location
Netherlands
Salary
€60,000 - €90,000 per year
Posted
14 Jun 2021
Closes
07 Jul 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Upsilon Global are working with a global CRO who are headquartered in the US and have 3,000 + employees in over 30 countries globally. 

The CRO has over 25 years of experience working in the clinical research field and pride themselves to have been awarded 1st Place in the CRO quality award and CRO awards in leadership.

Our partner is rapidly growing and is now looking for a Clinical Trial Manager to lead their medical device studies

Lead clinical team providing daily work direction to clinical study team members to support needs of clinical site, and work to meet goals and timelines of Sponsor, including determining
study objectives, strategy, scope, and schedule to meet Sponsor’s needs;
-Coordinate and manage project start-up, project maintenance, and project close-out
activities;
- Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for
Sponsor and all project team members;
- Track study status and progress according to milestones, identify and anticipate potential
issues or challenges, and work with team to develop appropriate solutions;
- Provide project management oversight of Project Coordinators, Clinical Trial Assistants,
Clinical Research Associates and other clinical study team members;
- Develop Study management tools, including communication plan, Clinical Monitoring Plan,
patient recruitment and -retention plan, and other study-specific documents –and
management tools;
- Communicate change in scope to Sponsor clinical team and Medpace Account Manager;
- May be responsible for other projects and responsibilities as assigned; and
- Provide input on the following (as applicable):-  Study protocol/Clinical Investigation Plan
- Edit check specifications
- Data analysis plan
- Data clean-up results
- Analysis

- Final study report

Qualifications:

Minimum Bachelor’s degree in Life Sciences or related field and 3 years of related medical device industry experience (e.g., clinical monitoring or project management), or Master’s degree in
Life Sciences or related field and 2 years related medical device industry experience (e.g., clinical monitoring or project management);
- Prior experience with medical devices trials is preferred;
- Exceptional communication skills (oral and written);
- High attention to detail and quality standard;
- Strong time and project management skills;
- Strong customer service focus;
- Demonstrate appropriate judgment in making decisions/seeking supervisor support;
- Provide project-specific oversight of Project Coordinators, Clinical Trial Assistants, Clinical Research Associates and other team members;
- Demonstrate measurable knowledge of Good Clinical Practice for medical device trials in the US (21 CFR 812 and other sections) and/or Europe (ISO 14155), and local regulations; and
-  Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.).

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