[Close] 

Senior Project Manager - CRO/Bid Defense

Summary:
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.
Candidates applying for this position should have strong background working as a Sr. PM in a CRO environment. Candidates should be well rounded in terms of therapeutic knowledge and should also have bid defense experience.
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.
Sponsor liaison
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.
Internal communication
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.
Project conduct
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.
Degree in Life Science, nursing background and/ or combination of education/experience.
Minimum 5+ years expereince of project management for clinical trials, including experience with oncology, asthma, etc.
Successfully managed a large size trial from set-up, until the end and final deliverables.
Clinical trial phases I-IV, preferrabely emphasis with phases II-III.
Mutiple theraputic area experience, such as, oncology, infectious disease, respritory, GI, etc.
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.)
Prior experience attending bid defenses and kick-off meetings.
Ability to work independently.
Good leadership skills and decision making skills.
Good reporting 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.
Requirements:
Degree in Life Science, nursing background and/ or combination of education/experience.
Minimum 5+ years expereince of project management for clinical trials, including experience with oncology, asthma, etc.
Successfully managed a large size trial from set-up, until the end and final deliverables.
Clinical trial phases I-IV, preferrabely emphasis with phases II-III.
Mutiple theraputic area experience, such as, oncology, infectious disease, respritory, GI, etc.
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.)
Prior experience attending bid defenses and kick-off meetings.
Ability to work independently.
Good leadership skills and decision making skills.
Good reporting 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.
Type:DirectLocation:Remote



Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Audit Project Manager - Technology
Gresham, OR U.S. Bank
Commercial Dealer Services Senior Portfolio Ma...
Portland, OR US Bank
Senior Claims Adjuster (Senior Resolution Mana...
Portland, OR Gallagher
Project Manager, Advisory
Myrtle Point, OR Fiserv, Inc.
Facilities Project Manager - Code Compliance
Portland, OR Portland Community College