Clinical Project Manager

• Job Title: Clinical Project Manager 
• Location: Germany (Remote) 
• Company: Mid-sized CRO 
• Salary: 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 global offices across North America, APAC, and Europe. They are currently in an expansion phase after the acquisition of two niche CROs in both Eastern and Western Europe where they plan to develop their clinical operations team. They are truly one of the most exciting growing CROs in Europe right now and cover a wide range of therapeutic areas. 

All applicants will be reviewed directly by the Head of Clinical Project Management in Europe who is personally reviewing and interviewing all applicants for this position. The Senior CPM will be among one of the early hires within the European study team and will become a natural leader within the department. They will be expected to have hands-on experience managing global trials within rare disease 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 a great opportunity to network with an expanding company and the Head of Global Project Management who is creating a talented team of Global Project Managers. It is also a great chance to become an early leader within a new department and contribute towards interesting rare disease studies.

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
• 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.

Requirements

• Life science degree or equivalent
• Minimum of 3+ years project management experience within CRO setting

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1293 584 300

Please click ‘apply’ or contact Paul Adam 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.

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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.