Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. This is Important Work
Provide leadership in managing multiple Phase I through to Phase IV international clinical trials with a variety of therapeutic areas. Coordinate all trial activities across functional departments and vendors according to the Contract and scope of work. Be accountable for the successful management and completion of assigned clinical trials where success includes the following: on-time, on-budget, according to SOPs, ICH- GCP and local regulations, in accordance with high quality standards and contract specifications. Serve as a primary contact for the Sponsors to ensure that the study conduct and completion are progressing according to the Sponsors needs and expectations. Your Role
Responsibility is broad, including but not limited to:
- Sponsor liaison ensuring high sponsor satisfaction
- Project assessment and initiation
- Resource planning and procurement
- Project implementation
- Ensure effective communication channels exist and are managed across cross functional team including third party vendors
- Manage the selection and contract of third party vendors.
- Milestone planning and tracking
- Ensure that projects are progressing according to the contract and high quality standards
- Ensure that projects are being managed according to SOPs, ICH/GCP and local regulations
- Ensure the contractual and financial aspects of the project are managed within timelines and agreed budgets
- Production of key project progress reports
- Act as substitute Project Manager in the absence of a Project Manager
Primary role of the Project Manager
- Lead clinical trials across functional departments within a variety of therapeutic areas.
- Work independently with periodic direction and review from PM Management.
- Actively participate in proposal development teams and participate in bid defences for assigned RFPs.
- Serve as the primary sponsor contact at the project operational level. Establish effective relationship with the Sponsor team to ensure that Sponsor needs and expectations are identified.
- Establish regular communication with the Sponsor. Escalate/communicate issues and propose solutions to problems.
- Provide Sponsor with study status updates at required frequency.
- Ensure effective communication channels includes all relevant team members (internal team, Sponsor and third party vendors) and comprises all project specific topics such as scope of work, timelines, project goals, technical information and Sponsor input.
- Report to appropriate line managers any anticipated resource or training needs or performance issues.
- Update the Project Review Form and financial Progression Chart and discuss these forms at the monthly Project Review Meeting.
Project initiation and planning
- Participate in the Business Development handover meeting to understand the history of the project, the scope of the contract and any Master Services agreement in place for the Sponsor.
- Review the project contract and associated budget to have good understanding of the contract scope of work, budget, project timeline and payment schedule.
- Identify resources needed and request resources from appropriate functional heads. Assign individual project responsibilities. Monitor ongoing resource needs for assigned project.
- Initiate and manage kick-off meeting with internal team, third party vendors and Sponsor to facilitate the understanding of the scope of work
- If appropriate, negotiate scope of work and manage third party vendors including but not limited to: central laboratories, storage units, couriers, meeting planners, sub-contractors for printing, monitoring, data processing, etc. Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
- Establish regular communication within the project team and co-ordinate study specific training for the project team.
- Set-up, maintain and develop project tracking to review study progress. Ensure up-to-date tracking.
- If appropriate, ensure the development of Project Specific Operating Procedures by functional area.
- Ensure the creation, execution and revision, as appropriate, of the project plan and filing plan.
- Manage day-to-day operational aspects of the assigned project and scope of work.
- Hold team meetings on a regular basis to assess the overall status of the project and to ensure pro-active project management.
- Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc. Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
- Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
- Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
- Submit invoice requests, trial related invoices and payment authorisations to finance in a timely manner. Regularly track all expenditure and review for consistency with trial budgets.
- Organise quality check of filing of key study documentation.
Project close out
- Ensure all administrative close out procedures are completed.
- Ensure project is archived and all documentation is returned to Sponsor as specified contractually.
Required Education and Qualifications
- Line managed by PM Management.
- Collaborate with Pharm-Olam Project Managers and project team members.
- Collaborate with all departments at Pharm-Olam.
- Collaborate with line management of project team members.
- Liaise with Sponsor staff.
- Liaise with third party vendors.
- MD, Life Science, nursing background and/ or combination of education/experience
- Successfully held responsibilities as international Lead CRA role or other management role.
- Ability to travel, on average 20-30% or less.
- Good leadership skills and decision making skills.
- Ability to work across multiple functions and cultures.
- Ability to travel domestically and internationally as required.
- Excellent English communication skills: written and verbal.
- Strong organizational skills and ability to deal with competing priorities.
- Strong reasoning and creative solving skills.
- Good presentation skills.
- Maintain up-to-date knowledge of ICH-GCP, EU CT Directive and FDA regulations.
- Proficient in the use of computer software systems (Word, Excel, PowerPoint, Share Point, CTMS, timesheet software, EDC software, etc.).
Please apply online at #removed#-olam.com/careers
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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