Senior Clinical Study Manager

Senior Clinical Study Manager

The company is a leading European company in the field of biomedical technology.

The Senior Clinical Study Manager will be responsible for all operational aspects of one or more medical device clinical trial(s) or registries (pre and post approval) under the leadership of Director of Clinical Affairs. Support all scientific aspects of clinical trial(s) as assigned.

Responsibilities

* Oversee the set up, management and closure of clinical trials and registries, ensuring contracts, fees, master file, tracking, device supply, randomization and blinding as applicable, submissions, site selections, training, device accountability as applicable, safety reporting, data monitoring and management, adjudication and all operations running in accordance with the plans, applicable SOPs, standards, and laws.
* Lead the development of Clinical Investigation Plan and related documents in collaboration with all internal and external contributors and stakeholders.
* Develop project plan, deliverables, timelines, and budget. Monitor and track status and quality throughout project and escalate issues at any stage, possible delays or budget overspend in a timely manner.
* Supervise the setup of study master files by Clinical Trial Assistants and Coordinators, supervise translations, and ensure country specific requirements are followed in collaboration with monitors.
* Liaise with Clinical Operations Manager for clinical suppliers, internal team assignment, resource needs, budget, and gaps in the processes or procedures.

You're Profile

* 10 years experience in clinical research (industry or CRO) and > 6 years experience in clinical study management.
* Certification training on ICH/GCP or ISO norms 14155
* Knowledge of cardiology, stent study experience is a must
* Interventional cardiology

For a confidential discussion, please call Paul Henschel at Real Pharma Zurich

0041 (0) 43 508 097 2 / p.henschel (at) realstaffing.com. This position is one of 10 positions, which I hold at the moment, so if this position doesn't suit to you, please let me know as there will be others which are relevantTo find out more about Real Staffing please visit www.realstaffing.com