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Job Details

Clinical Safety Manager

Company: Medpace
Location: London
Reference: 2016-2496
Closing Date: 22 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team!Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our UK team and to be based at our growing Stirling office. ...

Requirements:

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team!

Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our UK team and to be based at our growing Stirling office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.



DESCRIPTION OF JOB DUTIES

* Lead Clinical Safety activities for multiple trials and Sponsors;
* Manage relationships with clients and internal stakeholders by providing expert safety knowledge;
* Oversee clinical safety case management and aggregate reporting responsibilities of line reports to ensure client needs are fulfilled to high quality;
* Generate periodic and annual safety reports. Effectively manage accurate and timely distribution to Regulatory Authorities, Ethic's Committees and investigator sites
* Provide safety review of clinical study documents, including protocols, study reports; and marketing application components.
* Create safety management plans dependent upon client;
* Revise departmental SOPs and Work Instructions
* Assist in business development activities such as presentations to prospective Sponsors and participate in Sponsor audits



QUALIFICATIONS/REQUIREMENTS

* Bachelor’s degree or equivalent and 5 years clinical safety experience; project management experience preferred
* Comprehensive knowledge of global clinical safety regulatory requirements;
* Previous experience in preparing periodic and annual safety reports
* Effective management of distribution of expedited reports, periodic and annual reports to Regulatory Authorities, Ethic's Committees and investigator sites in accurate and timely fashion
* Development of clinical safety documents e.g. safety management plans
* Past supervisory experience preferable;
* Excellent verbal and written communication skills;
* Strong leadership, mentoring, and motivational skills;
* Exceptional teamwork skills;
* Ability to work independently.



WHY MEDPACE?

At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.



WHAT TO EXPECT NEXT

We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

Apply for this job: Clinical Safety Manager

Contact Information:

Address:  Medpace, Inc
5375 Medpace Way
Cincinnati
Ohio
45227
USA
Tel:  +1 513 579 9911
Fax:  +1 513 579 0444
Website:  Visit Our Web Site

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