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Project Manager

3 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 project-specific 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 project-specific documents.
- Act as the lead contact for project-related matters and, if assigned, as the cross-functional 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 start-up, active recruitment phases, data cleaning and database lock, close-out 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 5-7 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 cross-functional teams and external vendors.
- Proven leadership abilities, including mentoring team members and leading cross-functional study teams.
- Strong analytical and problem-solving 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 fast-paced 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.