Contract Clinical Project Manager - Vaccines - Usa

RBW Consulting are delighted to announce an exciting opportunity on behalf of one of our close clients. This company is a full-service CRO with global offices across North America, APAC, and Europe. They are currently in an expansion phase after the acquisition of two niche CROs in Europe and they plan to develop their clinical operations team worldwide. They are truly one of the most exciting, growing CROs in the world right now and cover a wide range of therapeutic areas.

The Contract CPM will be joining a diverse and talented project management department which is lead by a forward thinking Director of Global Project Management. As a Contract CPM you will be expected to have hands-on experience managing global trials within Vaccines studies at a high level. They will be client-facing and will actively support in developing request for proposals with biopharmaceutical clients, selecting suitable staff, creating BID language, and developing milestones in accordance to agreed timelines and budgets. They may also be expected to take on a strategic role with the client if required.

This is an excellent opportunity to network with an expanding company and the Director of Global Project Management who is creating a talented team of Global CPMs. It is also a great chance to contribute towards interesting Vaccines studies.

Typical Responsibilities Include:

• Maintaining scope change log and execution Change Orders / Budget Amendments as needed.
• Manage study-related vendor deliverables per SOW and study timelines
• Maintain project financial health through review of monthly activities against current SOW, and addressing change orders in a timely manner
• Manage all study specific vendors contracts as applicable (per project scope and company contract scope)
• Communicate effectively and efficiently with clients, vendors, and internal team
• Provide strong, independent Clinical Operations leadership on assigned and/or complex projects
• Ensure team members are adequately trained on the project to perform their assigned tasks and services.
• Close oversight of site management team activities from site startup through closeout. Depending on the study, SPM may be involved directly interim calls to site and troubleshooting as needed. Work with the Clinical Trial Manager, CRAs, and CTSs to ensure protocol training, site protocol adherence and query resolution is adequately supported.
• Design and implement study specific project plans, logs, and actions to keep project on track
• Oversee adequacy of trial master file setup and maintenance is maintained throughout the trial by assigned team members.
• Ensure projects are adequately staffed according to budget, SOW, and capabilities, and escalate to management when issues are present or anticipated that will require modifications
• Assists with ongoing review of data during trials, as needed
• Ensure adequacy of CRF design and development for the trial
• Assists in developing relationships with new and existing clients
• Communicate / escalates project risks to Project Director and/or direct report (line manager) as appropriate
• Manage protocol and ICF development as applicable.
• Ensure clients are provided with trackers, reports, and logs as needed and on time per SOW Develop and deliver dashboards and Executive Summary Reports as required by clients and per SO
• Continues to develop processes with the growth of the area and incorporate those processes with other departments
• Ensure company or sponsor selected vendors are adequately supported from contracting through training /onboarding, and throughout the trial
• Prepare and maintains project financial workbook each month, including forecasting updates from study start through closure
• Ability to manage and execute complex trials, including timeline development, taking on a strategic role with the client if needed, and developing customized processes, materials, and/or plans to support trial needs
• Serves as primary contact with clients and vendors, establishing communication mechanism and formats that meet the needs of all parties supporting the trial
• Oversee and ensure company site selection process is successful through oversight of feasibility questionnaire development, management of workflow, and reviewing record of processes managed by the assigned clinical staff
• Establish team roles and responsibilities and Provide clear direction to internal team and vendors to ensure study success
• Oversee and ensure delivery of timely project deliverables for all functional areas of the project
• Mitigate risks where and when needed to ensure project success
• Ensure data deliverables are complete and current throughout the trial through regular review of data management reports, review of monitoring activities, and site management reports (as applicable)
• Participate in development and strategizing on any proposals or bids to external customers

Requirements

• Global level pm experience would be beneficial
• Based in the USA
• At least 2 years of Vaccines experience
• Minimum of 5+ years project management experience within CRO setting

The contract

• 6 months (extension highly likely)
• $ DOE
• June start
• 1 FTE desired

Please apply here and Harry Henson will be in touch for a confidential discussion around your application.