Clinician (FSP) at Parexel

, , China -

Full Time

Start Date

Immediate

Expiry Date

29 Mar, 26

Salary

0.0

Posted On

29 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Protocol Development, Project Management, Communication Skills, Good Clinical Practices, Data Monitoring Committees, Investigator Engagement, Clinical Expertise, Regulatory Knowledge, Training Materials, Site Management, Recruitment, Leadership Experience, Fluent English, Host Country Language

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: General Accountabilities • Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products. • Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members) • Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings . • Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes. • Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities. Compliance with Parexel standards Comply with required training curriculum. Complete timesheets accurately as required. Submit expense reports as required. Update CV as required. Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements Strong Communication Skills Demonstrated project management / leadership experience Skills: • Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations. Knowledge and Experience: • Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes. Track record of design, oversight and interpretation of clinical studies. Previous leadership /management experience or training. • Knowledge and experience in Good Clinical Practices. • Fluent in both oral and written English. • Fluent in host country language required. Education: • Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The clinician provides clinical and scientific expertise to the clinical trial strategy and protocol development process, collaborating with various internal and external contributors. They also maintain direct contact with investigative sites to facilitate engagement and support enrollment activities.