Job Description

  • Department: Medical Affairs
  • Reports To: Associate Vice President, Clinical Operations
  • Location: Singapore

 

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
  • Participates in the selection of study vendors for assigned studies
  • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
  • Develops, reviews and refines clinical protocols, statistical analysis plan, clinical study reports, study charters and clinical operational plans including the study monitoring plan and other plans as needed
  • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
  • Develop and manage study timelines (including recruitment) and may develop and manage program timelines
  • Participates in the selection of investigational sites with input from Clinical/Medical operations and vendors
  • Assists with protocol design and medical issue resolution
  • Proactively identifies project risks and resolution
  • Participates in study data review and other review activities as assigned
  • Oversees clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
  • Leads ongoing review of data to ensure GCP
  • Oversees the submission of trial-related and essential documents to the Trial Master File
  • Identifies and provides solutions to clinical trial issues and/or risks
  • Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated
  • Provide or facilitate training to clinical study teams on assigned protocol specific topics
  • Work closely with other teams in the organization, e.g., quality, regulatory, etc.
  • Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested.
  • Provide guidance to Medical Affair team on Investigator Initiated Trials.

 

Qualifications:

  • BS or Master’s Degree in nursing, life science, or related field (or equivalent experience)
  • Minimum of 3 years of clinical research experience (at least 1 of which are as a Project Manager) for clinical studies at a CRO and/or pharmaceutical/biotech organization
  • Previous experience negotiating vendor/site contracts and managing the budget
  • Thorough understanding of FDA, ICH and GCP guidelines
  • Proven track record showing clear proficiency in clinical project management skills
  • Proven complex problem-solving skills
  • Solid vendor management skills, e.g., CRO, laboratory & clinical supply logistics
  • Broad understanding of clinical operations related to clinical development functions
  • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
  • Ability to effectively interface with medical personal at clinical site(s)
  • Ability to lead multi-disciplinary, cross-functional team leadership and participation skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency with computer programs including Microsoft Office suite and Microsoft Project
  • Ability and willingness to travel internationally

 

Other information:

  • Location: Singapore
  • Job Type: Full Time

Application process:

Please send the followings to emily.lim@moleac.com

  • Cover letter
  • Resume
  • Expectations: Salary
  • Availability

We regret that only shortlisted candidates will be notified.