SSU Clinical Operations Manager

SSU Clinical Operations Manager - Taiwan, Taipei – Permanent

is actively recruiting for a Study Start Up Clinical Operations Manager to join our expanding global company in Taiwan – this is a permanent office based opportunity in Taipei. The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. By working for Company you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description
The SSU COM will be accountable for the execution and oversight of local operational clinical trial activities in Country. The COM will also be responsible for local regulatory and financial compliance for assigned protocols.

Responsibilities:
* Take ownership of country and site budgets
* Develop, negotiate and complete of Clinical Trial Research Agreements (CTRA)
* Oversee and track clinical research-related payments
* Perform reconciliation of payments at study close-out
* Track financial forecasting of the operational budget in conjunction with Clinical Research Director
* Execute and oversee the clinical trial country submissions and approvals for assigned protocols
* Develop local language materials including local language Informed Consents and translations
* Manage country deliverables, timelines and results for assigned protocols to meet country commitments
* Collaborate closely with Regional Operations to align country timelines for assigned protocols
* Provide support and oversight to local vendors as applicable
* Oversee and coordinate local processes
* Manage supplies, drug supplies and supplies destruction, importation and exportation requirement, archiving and retention requirements, and insurance process
* Maintain country information in clinical, regulatory, safety and finance systemsEssential Criteria:
* Educated to Bachelor's Degree (or comparable) in Business Finance, Administration, Life Science or equivalent Health Care related experience
* 5-7 years’ clinical research experience
* Extensive experience in clinical project management and coordination
* Expertise of core clinical, regulatory and financial systems, tools and metrics
* Extensive knowledge of local regulatory environment and submission and approval processes
* Strong communication and leadership skills
* Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
* The ability to focus on multiple deliverables and protocols simultaneously is essential
* Ability to work effectively also in a remote virtual environment with a wide range of people
* Fluency in English and Mandarin
* Ability to work office based in Taipei

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Gloabl Recruiters 2017

Application Email: ILYU.29397.3273@sthreesg.aplitrak.com