Clinical Trials Manager (Principal US Pharmaceutical MNC, GCP)
About the Role
- The Clinical Trial Manager will support successful design and day-to- day execution of clinical trials from concept through publication.
- Key accountabilities include successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as managing clinical project timelines, budgets, deliverables, and overall communications.
- Execute deliverables of all aspects of assigned clinical studies including but not limited to: investigator selection, study startup, authoring/preparation of study-related documentation (e.g., protocols, case report forms, consent documents, laboratory and study procedures manuals, etc), study conduct and close out activities.
- Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
- Independently manage Clinical Research Organization and other vendors, including contracts, budgets and invoicing.
- Provide regular updates of study progression to Director, Clinical Operations, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Identify barriers to timely and successful study execution and propose solutions to same.
- Provides monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports.
- Works on study feasibility assessments and selection of countries and sites for study conduct.
- Assure compliance with all regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities.
- Drive data collection, clinical trial database construction, and assist with necessary audits of data to ensure data integrity.
What We're Looking For
- Min BA/BS degree with at least 5 years’ of clinical trial management industry experience (biotech, pharma or device)
- Must have strong working knowledge of clinical protocol development, clinical study design, study planning and management, and site monitoring
- Strong experience in management of CROs and other vendors
- Working knowledge of GCP, ICH guidelines and other US/SG and international clinical regulatory requirements
- Ability to work independently as well as part of a cross functional team
- Requires proven project management skills and study leadership ability
- Excellent problem solving skills, verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
- Ability to travel as required (~25%)
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Clinical Trials Manager - Leon)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Recruit Express Pte Ltd