A historic pharmaceutical company is seeking to recruit a Clinical Program Operations Lead to their office in Surrey. The organisation creates informative and engaging online communities that share information in meaningful ways. This vacancy offers an exciting opportunity to work with a leading and innovative pharmaceutical organisation that develops high quality medicines that meet real needs.
The Clinical Program Operations Lead will oversee the creation and execution of the exploratory and biopharmaceutics clinical operational development plan at a molecule level, providing technical leadership and operational oversight of clinical research trials within the development plan. They will be responsible for all aspects of global clinical trial operations within the plan as the single operational point of contact, from trial design through execution and close out, including co-ordination of right to operate documents, timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment, and retention and budget management.
Job Responsibilities:
- Consulting with the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, and publications and manuscripts.
- Maintaining expertise of meaningful disease states/targets, competitors, industry trends, and operational requirements to effectively plan in detail the studies and submissions.
- Leading the implementation and integration of clinical project management processes and tools.
- Collaborating with Third Party Organizations (TPOs) and cross-functional partners to execute the clinical strategy, key compound, and trial deliverables on time and within budget.
- Actively identifying and communicating clinical risk assessment and mitigation/contingency plans within team and to functions and leadership.
- Actively participating in the selection process and providing day to day oversight for operational deliverables with external network of vendors to ensure delivery of the clinical project.
- Serving as the central point of contact for the global clinical team, resolving clinical implementation issues, leading risk assessments and contingency planning, and effectively communicating across and upward.
- Documenting key decisions, actions, and key modifications in clinical scope, resources, and timeline.
- Overseeing the accurate collection and communication of clinical metrics.
- Archiving all relevant clinical information at the termination of a project and as appropriate throughout the project.
- Building and developing key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
- Effectively communicating clear and concise information and leveraging influence at all levels across the organisation to enable decision-making by team and governance/Stakeholders.
Skills and Requirements:
- Bachelor's degree in a science related discipline from an accredited college or university. An advanced scientific degree would be preferred.
- At least 3-years' experience in the pharmaceutical industry in a role providing direct experience of leading clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year experience preferred).
- Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
- Demonstrated knowledge and experience with project management tools and processes, managing vendors and contract experience
- Able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent recurrence within the team.
- Validated experience of coaching and mentoring others.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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