전문인력 알선업체인 파라곤컨설팅(www.prgconsulting)입니다 저희 고객사인 강남구 소재 다국적 제약회사에서 하기와 같이 임상담당 Manager (Clinical Trials Manager)를 찾고 있습니다

관심있는 분은 하기의 이메일 주소로 영문이력서(희망연봉표시)를 전송해 주시기 바랍니다

제출처: suchoi@prgconsulting.co.kr

연락처: 최성웅(파라곤컨설팅): 핸드폰/019-252-8747

Qualifications:

1. Majored in Pharmacy, Science of Nursing, Clinical Pharmacology, Pharmacodynamics, Pharmacokinetics or related disciplines

2. More than5 years of experiences in the clinical research and trials

3. Good command of English is preferred

Responsibilities:

-Develop Investigational Plan

-Develop protocol, ICF(Inform(block)ed Consent form(block)) template, and CRFs(Case Report form(block)s)

-Oversee the Clinical team internally and externally to ensure the successful implementation of clinical initiatives.

-Develop clinical trial timelines.

-Manages clinical trial budgets.

-Manage study vendors; to include oversight of clinical supplies, CRO, data management groups and core laboratories.

-Develop study tools for implementation and tracking of study activities.

-Initiate site selection plan for new clinical trials and investigator sites.

-Communicate with sites and resolve inquiries and problems related to clinical investigation.

-Manage trial enrollment to meet timelines.

-Assist with obtaining required legal, ethical and technical agreements with sites participating in studies.

-Prepare clinical data for internal use, presentations and as needed for regulator submissions.

-Provide clinical data when needed for presentations, monographs and publications.

-Oversee, review and approve case report form(block)s, investigator qualification reports, site initiation reports, and monitoring reports.

-Plan, organize andparticipate in investigator meetings, ad hocscientific advisory board meetings.

-Maintain a high level of professionalexpertise through familiarity with clinicalliterature and participation in project meetings.

-Mentor CTSs and CRAs