The Clinical Operations Manager will be an active part of the Medical Affairs team contributing to Moleac’s drug development program to build scientific evidence of our products and introduce new product to the global market with the potential to address the needs of patients’ recovery from a loss of brain functions after a brain injury (Stroke, Traumatic Brain Injury). You will be reporting to the Associate Vice President, Clinical Operations and will be entrusted with a wide range of responsibilities, and have the opportunity to grow and develop with the company.
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.
> 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
> Location: Singapore
> Job Type: Full Time
Please send the following to [email protected]
> Cover letter
> Expectations: Salary
We regret that only shortlisted candidates will be notified.