Ref #: 28212

Employment type: Permanent - Full-Time

Location: China-Beijing

Description

Overview:
Contribute to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the concerned clinical studies (e.g. study protocol, CRF, Investigator Brochure, clinical study report), also representing the Company in front of the institutional authorities concerned. Support the relevant clinical studies according to the clinical development program relative to all medical/scientific aspects, especially those requiring Therapeutic Area expertise, where he/she is deeply committed to act as the main reference point on the team.

Main responsibilities:
• Acting as a member of the Clinical Team, conduct and deliver the results of the assigned Clinical Studies and complete the related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines (e.g. clinical section of the investigator’s Brochure, clinical section of the Investigational Medical Product Dossier, DSUR, assigned Protocols, Protocol amendments & Clinical Study Reports, manuscripts).
• Provide clinical input to functional portions of the Clinical Development Plan (e.g. study design, endpoints, patient population, Inclusion/Exclusion criteria), cooperation to the timely and quality execution of the plan through interaction with Study Team Members, blind review meeting).
• Ensure the safeguard of Patients Safety: in collaboration with and in support of Pharmacovigilance, identify safety signals, review narratives, take actions with investigators when Serious/unexpected Adverse Events are reported, ensure a full understanding of key Adverse Events and Serious Adverse Events and appropriate actions.

Required experience and qualifications:
Education: Medical Doctor Degree or equivalent; certification in Respiratory Diseases/Pulmonology is highly desirable

Required experience/background: A significant experience in clinical or academic research in the respiratory field. At least 2 years in the pharmaceutical industry within the specific therapeutic area (respiratory) is considered as a valid alternative.

Technical skills: Experience in writing protocols/reports, publications, preparation of clinical development plans, review of literature, managing advisory boards.

Managerial skills: ability to integrate and explain complex data, excellent presentation skills, excellent verbal & written communication, ability to lead a cross-functional team and drive sound decision making, sharp focus on delivering results and solving problems, unwavering commitment to quality and the highest ethical standards, high degree of responsiveness, teamworking, persuasiveness and influencing skills.

Languages: fluent English, both spoken and written

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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