Clinical Project Manager

• Job Title: Clinical Project Manager
• Therapeutic Area: Ophthalmology
• Location: Remote (anywhere in United States)
• Company: Niche CRO (30-50 employees)
• Salary: $135,000 - $150,000 (depending on experience)

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 30-50 employees focusing on the medical device, biotechnology, and pharmaceutical industries. This company work with a mixture of start-up clients and well established sponsors within the life science space and are expanding their book of business consistently year upon year since their conception. This company work with multiple therapeutic areas and is now looking for a talented Senior Clinical Project Manager (CPM) with a background in ophthalmology studies. They cover all phases including pre- and post-market studies and are fully equipped to support end-to-end research within the full study lifecycle.

This is a great opportunity to join an agile and expanding company that is big on culture. They go to great lengths to ensure their staff are not over-burdened with too many studies or an overflow of clients. They want to make sure their project managers are given the space and tools necessary to deliver a high quality of work to their clients. CPMs here are typically assigned 2-3 studies depending on the size of each project.

Typical Responsibilities Include:

• Provide strong, independent Clinical Operations leadership on assigned and/or complex projects
• Communicate effectively and efficiently with clients, vendors, and internal team
• Establish team roles and responsibilities and Provide clear direction to internal team and vendors to ensure study success
• Serves as primary contact with clients and vendors, establishing communication mechanism and formats that meet the needs of all parties supporting the trial
• Participate in development and strategizing on any proposals or bids to external customers
• 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
• 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
• Manage protocol and ICF development as applicable.
• 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
• Design and implement study specific project plans, logs, and actions to keep project on track
• 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 company or sponsor selected vendors are adequately supported from contracting through training /onboarding, and throughout the trial
• Manage all study specific vendors contracts as applicable (per project scope and company contract scope)
• Manage study-related vendor deliverables per SOW and study timelines
• Ensure adequacy of CRF design and development for the trial
• 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.
• Maintain project financial health through review of monthly activities against current SOW, and addressing change orders in a timely manner
• Maintaining scope change log and execution Change Orders / Budget Amendments as needed.
• Prepare and maintains project financial workbook each month, including forecasting updates from study start through closure
• Assists with ongoing review of data during trials, as needed
• Continues to develop processes with the growth of the area and incorporate those processes with other departments
• May assist in developing relationships with new and existing clients
• Communicate / escalates project risks to Project Director and/or direct report (line manager) as appropriate
• Ensure team members are adequately trained on the project to perform their assigned tasks and services.
• Oversee adequacy of trial master file setup and maintenance is maintained throughout the trial by assigned team members.
• 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)
• 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 SOW

Requirements:

• Life science degree or equivalent
• Minimum of 2+ years project management experience within CRO setting
• Experience in Ophthalmology research
• Experience working in small or mid-sized companies

Benefits:

• Flexible work week hours
• Full health benefits plan (medical, dental, and vision)
• Health and dependent care flexible spending accounts
• Paid vacation
• 401(k) plan

To apply:

Please click ‘apply’ or contact Joe Pearce for any further information.

About RBW Consulting:

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients. We give back by playing an active role in funding initiatives that change lives. We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency:

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.