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 [email protected]
- Cover letter
- Resume
- Expectations: Salary
- Availability
We regret that only shortlisted candidates will be notified.
