Project Manager

2 weeks ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time

Manage assigned clinical trials by scheduling, reviewing, and driving project tasks and deliverables within a clinical team and cross-functional team leads.


  • Prepare and review project status reports to ensure timely completion of project objectives in compliance with all regulations and SOPs.
  • Follow up on projectspecific deliverables across the team and external bodies to ensure timely completion of required tasks.
  • Manage project costs and participate in the contract execution process.
  • Develop, maintain, and approve study documents, including but not limited to Study Management Plans and Communication Plans; implement development of QMS, SOPs, and Company Policies.
  • Review clinical trial protocols, Investigator's Brochures, ICFs, study logs, and other projectspecific documents.
  • Act as the lead contact for projectrelated matters and, if assigned, as the crossfunctional study lead.
  • Interface with vendors/CROs involved in the trial and participate in periodic update calls/meetings.
  • Oversee and manage vendors/CROs/CRAs throughout site startup, active recruitment phases, data cleaning and database lock, closeout phases, and archiving.
  • Mentor other members of the project team when required.
  • Lead the TMF creation process and assist in TMF maintenance. Comply with regulatory, GCP, ICH, and SOP guidelines.

Job Requirements:

  • Bachelor's Degree in a related field such as Life Sciences, Nursing, Pharmacy, or a related discipline. A Master's degree or higher is preferred.
  • At least 57 years of experience in clinical trial management, including managing global clinical trials.
  • Demonstrated experience in managing clinical projects, including timelines, budgets, and deliverables.
  • Strong understanding and experience with regulatory requirements, GCP, ICH guidelines, and SOPs.

Skills:

  • Proficiency in project management tools and methodologies.
  • Excellent written and verbal communication skills, with the ability to effectively interface with crossfunctional teams and external vendors.
  • Proven leadership abilities, including mentoring team members and leading crossfunctional study teams.
  • Strong analytical and problemsolving skills, with the ability to anticipate and address issues proactively.
  • Experience in developing, maintaining, and approving study documents such as Study Management Plans, Communication Plans, and regulatory documents.
  • Experience in managing relationships with vendors, CROs, and CRAs.

Certifications:

  • Project Management Professional (PMP) certification is a plus.
  • Certifications such as CCRA, CCRP, or equivalent are preferred.

Personal Attributes:

  • Strong attention to detail and organizational skills.
  • Ability to adapt to changing priorities and work in a fastpaced environment.
  • A collaborative spirit and ability to work effectively in a team environment.

Technical Proficiency:

  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software tools.
  • Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams).

Additional Requirements:

-
Travel: Willingness to travel as required for project needs.
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