Senior CPM / Global Studies / Non-for-profit CRO / Remote / £85,000 - £95,000 plus package (depending on experience)
RBW Consulting are excited to announce an opportunity on behalf of one of our close clients. This company are a small, non-for-profit CRO with 400+ employees across 38 geographical locations throughout the USA, APAC, and Europe. They provide the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials. They have expertise in various therapeutic areas but in the UK their main focus will be in the fields of Neurology, Oncology, Hematology, or Rare Disease studies. This is where they have a strong pipeline as well as a healthy pipeline of upcoming studies.
The company plunge most of their profits back into their research and provide incredible scientific leadership from the top-down. They have a leading culture that is praised as 'family feel, transparent, and collaborative at all levels', and focuses on helping improve the lives of thousands of people affected by a range of conditions. Growth will be attainable in this position as the role has varied responsibilities compared to an average Senior PM opportunity. For example, you can touch upon the scientific, strategic, and oversight aspects of their studies. This opportunity is great for someone who enjoys project delivery but wants to do it at a higher level in a company where they can truly impact success.
Through providing the best clinical trials and delivering clear and concise data for the sponsors they partner with, they have a great track record of winning new business through word-of-mouth as well as capitalizing on retained business from their current sponsors. In short, this is a stable company with great perks, interesting research, and tangible opportunities to learn/grow within the company.
We expect this role to be highly contested and on the market for a short amount of time so do not hesitate to reach out or start an application.
The Senior Project Manager (SPM) is responsible for overseeing and coordinating all study management activities. On occasion, SPM will be requested to perform additional activities at a Program Management level as well as work with senior members of Clinical Operations to develop/review workflows, tools, and SOPs. The SPM is responsible for leading any and all assigned teams while demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. SPM work is performed under the general direction of the Senior Director, Clinical Operations, though it is expected the position requires minimal oversight and support (unless escalation is needed) once SPM is fully on-boarded with the company and/or has completed all transition activities for this senior level role.
Work is performed under the general direction of the Director of Project Management.
- 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
- Assists 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
- Ensure compliance with all applicable regulations, SOPs, contracts/agreements, and project plans,
- Mentor / coach junior team members as needed to support their success as well as to ensure the trial success. This level of support may include support / attendance at select Site Qualification, Site Initiation, Interim and Close-out Visits, and may be especially important for early phase trials to support client expectations.
- Coordinates and participates in internal and external project team meetings as needed
- Participates in company, staff, and departmental meetings
Compliance and Training
- Complete and document mandatory training for this role within specified timelines
- Attend and document mandatory training workshops required for this role
- Comply with all applicable regulations, guidelines, SOPs and project-specific requirements
- Comply with all designated systems relevant to this role
- Ensure own quality control of all relevant processes and activities performed
- Report and escalate identified issues in areas of responsibility according to company and/or project requirements
Customer Focus and Teamwork
- Attend and actively participate in company meetings and other internal meetings as required
- Provide input to systems, tools and process improvement
Work Health and Safety
- Comply with Work Health & Safety (WH&S) legislation and operate in accordance with established organisational WH&S practice and procedures
- Promote and contribute to a safe, secure environment for staff and visitor
Skills, Knowledge and Experience
- CRA or site management experience and bachelor’s degree strongly preferred. Oncology project management experience required. Five to seven years of oncology Project Management experience and/or training; OR equivalent combination or education and experience in oncology and project management related roles.
- Must have exceptional communication skills in both verbal and written form
- Must have excellent organizational and time management skills
- Must have an understanding of GCP’s and regulatory requirements of the FDA
- Must be skilled in the area of delegation and task follow-up Must have experience with the following software: Word, Excel, Power Point and Adobe Acrobat
- Must be able to prioritize multiple projects and coordinate these efforts
- Must be able to maintain confidentiality of information and procedures developed
- Must be able to work on complex projects involving various research and ancillary entities
- Must be able to promote a positive, productive, and partner-oriented customer service attitude with clients
- Maintain professional, positive, and motivational working relationships with staff, vendors, and clients as representative of company team leadership principles
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1273 049 215
Please click ‘apply’ or contact Joe Pearce for any further information
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