This is an exciting opportunity to join ICON
Operations Lead - Study Start Up & RA Specialist
China (Office / Home based)
ICON's award-winning study execution capabilities have led to the approval of 18 of the world's top 20 best-selling drugs. ICON seek an expert pharmacovigilance professional with expertise in managing client relationships and projects along with the know-how of mentoring a team.
We're on the lookout for a ICON are currently looking for a Clinical Regulatory Specialist to join our Real World Evidence team in China. Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices.
Role Responsibilities include:
The Regulatory Specialist works closely with the site contracts and ethics and regulatory teams in providing support in managing all regulatory aspects of the assigned projects in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs.
The primary focus of this role is to;
* Responsible for oversight of regulatory and ethics submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.
* Responsible for oversight of studies start-up phase until SIV completion, ensuring that all start-up activities are performed within the defined timelines.
* Responsible for providing advice and support to the project team for regulatory aspects of the clinical trials and late phase studies.
* Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.
* Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
* Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Clinical Regulatory Affairs activities.
* Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
* Responsible for liaising with other departments on requirements for regulatory and ethics submissions.
* Participating in the improvement of the Quality Assurance System.
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
* 3+ years of experience in clinical research including minimum 1+ years of relevant experience in study start up and or regulatory activities.
* Strong knowledge of ICH/GCH guidelines or other relevant guidelines (GEP, GPP or local requirements)
* Solid knowledge in China local regulatory requirements
* Bachelor's Degree or local equivalent and/or with appropriate experience from the Medical/science
background and/or discipline
* Good command of verbal and written English and overall excellent communication skills.
* Organizational, time management and interpersonal skills
* Ability to work independently and in a team environment
* Proficiency with computer systems
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.