Manager, Clinical Research

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, Scopus

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job 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.