Manager, Clinical Compliance/PH Company
2013-08-06
Great opportunity to build your career in international PH company with head office in Switzerland.
Our client Pharmaceutical Company is currently recruiting Manager, Clinical Compliance
Clinical Compliance Manager is responsible for overseeing medical device studies, Clinical Affairs consistency and compliance across the clinical trial programs. Plans and directs clinical audit plan, ensures SOP compliance and GCP guidelines are honored in a consistent fashion. Works with trial leaders and Clinical Operations as well as Regulatory Affairs and Quality to ensure processes are aligned and consistent. Reports directly to Senior Manager EU Clinical Trail Operations. Periodically reviews and develops Business Unit Clinical SOPs as needed.
Leads and counsels Clinical Affairs department level CAPAs for issues that arise requiring critical attention.
Monitors and evaluates Clinical Trial Activities in EU to ensure compliance and consistent trial conduct.
Reviews audit findings and collaborates with Clinical team to resolve observations. Advises Clinical team on clinical trial compliance issues as needed.
- Assesses training plans and assists with the development and maintenance of training plans as needed.
- Leads and/or participates in various projects to ensure accurate records and patient safety.
- Advises Director Clinical Affairs EU on trends or issues that may introduce risk to clinical trial programs.
- Assesses regulatory submissions, protocols and informed consent forms to ensure consistency and continuity. Reviews critical regulatory submissions.
- Develops clinical trial audit plans in collaboration with Clinical Operations based on study enrollment and site performance history.
Ideal candidates will have minimum of 5 years experience in clinical research ideally with medical devices studies. A track record of personal career development and clinical trial management experience is required, with Class II, III medical devices or Experience in cardiovascular surgery or interventional cardiology plus.
Strong project Management and leadership skills, willingness to travel (Germany and to Switzerland).
We offer to working in international company total rewards package which includes competitive compensation, excellent benefits, and career and development opportunities.
In case of interest please send your CV to ondruchova@hays.cz.
