Manager, Clinical Research
3 days ago
Job Description
Clinical and Regulatory
Strategy Development: Drive the clinical
development, expand
portfolio, and speed
up registration;Get alignments with Global
PDT and obtain
CDRC/LDRC endorsement.
Execution clinical &
registration strategy
Protocol Development:Accountable for protocol
development, approval
and amendment of China
stand alone phase I –III
and PMC.
Clinical Trial Execution:Feasibility assessment;
Medical monitoring
Regulatory Submission
& Interaction:CSA application, pre-IND,
IND, pre-NDA, NDA filing
and approval.
Innovation &
Scientific Engagement:MISP/OTSP studies
o Scientific
leadership; SIE(Scienti
fic inputs engagement)
etc.
; Publications
Required Skills:
Accountability, Adaptability, Bioinformatics, Chromatography, Clinical Development, Clinical Medicine, Clinical Research, Clinical Trial Development, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Data Analysis, Dedication to Patient Care, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, Investigation Procedures, Leadership Mentoring, Non-Disclosure Agreements, Quality Management, Regulatory Compliance, Regulatory Submissions, Root Cause Analysis (RCA), Scientific Research, ScopusPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noJob Posting End Date:
01/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R376369
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