ABOUT THIS ROLE
My client, an innovative Contract Research Organisation (CRO, based in Hertfordshire is looking for an experienced and ambitious Senior Clinical Study/Project Manager to join their team on permanent basis.
The successful candidate will be a subject matter expert; a role model and mentor to more junior colleagues and to lead on the clinical aspects of trial delivery. Working flexibly to ensure that study objectives and deadlines are met on budget and time, being proactive in developing and implementing procedures and work with a high degree of autonomy.
- Playing a pivotal role in proposal strategy, development, costing, and bid defence for assigned trials
- Initiating and driving improvements to enhance efficiency and quality.
- Proactively engaging in risk management activities to ensure key milestones and project deliverables are met according to both company’s and client requirements.
- You will be accountable to meet the financial performance targets for your assigned studies, responsible for performing forecasting, revenue recognition, maintaining profit margin and to proactively identify out of scope activities and execute necessary work scope change orders
- Establishing relationships with client teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. You will also be responsible for appropriate issue escalation
- Preparing regular communications/reports to client/sponsor/Investigation sites
- Organising and coordinate meetings and events as required on behalf of client/sponsor, circulating agendas and other information in advance and writing and disseminating minutes
- Managing workload priorities ensuring the more urgent and important tasks are completed first within required timescales
- Developing the clinical study protocol and ensure input, review and finalisation occurs within budget and timelines.
- Overseeing and/or creating all relevant operational documents required for the smooth running of the study, including project, monitoring, communication, quality and safety management plans according to company’s SOPs
- Completion/oversight of Ethics Committee (EC) and Competent Authority (CA) clinical trial applications in accordance with the company‘s SOPs
- Completion/oversight of applicable local submissions in accordance with company’s SOPs
- Conducting study Quality Control (QC) activities throughout the study lifecycle to ensure study processes are in line and compliant with regulations and in accordance with company’s SOPs/WIs
- Working alongside CTAs to ensure assigned projects have an appropriate clinical trial file, including Trial Master Files (TMF), In-House Investigator Site Files (hISFs), Investigator Site Files (ISFs), Pharmacy Files (PF), Laboratory Files, and in-house electronic files and are audit ready
- Liaising with CTAs to ensure distribution of essential documents such as protocols, investigator brochures, and clinical study reports to investigational sites for assigned projects
- Ensuring sufficient stocks of study related consumables at investigational sites, creating and maintaining trackers where required, for availability of stock for assigned projects
- Supporting monitoring activities for assigned projects by assisting the study CRA in preparation and follow up tasks as well as accompanying the study CRA on site visits as required
- Supporting study close out activities for assigned projects, including preparation of study documentation for archive, and collaborate with the site archivist to organise off-site archiving in accordance with applicable regulations
THE IDEAL CANDIDATE
Knowledge and skills
- 5yrs + demonstrated clinical research experience in a pharmaceutical company/CRO/CTU.
- Demonstrated line management experience
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Working knowledge of project management processes. Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently. Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel Desirables
- Familiarity with ISO 14155, and Medical Devices Legislation
Values and behaviours
- Organised, ability to multi-task, ability to motivate and organise others.
- Flexible and proactive approach with a “can do” attitude
- Delivers high quality work
- Willingness to accept and make changes in a fast paced environment.
- Strong leadership and motivational skills
- Able to work independently whilst also being a strong ‘team player’
- Promote and display Company values and ethos both internally and externally
- Will quickly get to know the organisation ethos and study workload
- Will effectively line manage staff (when required)
- Will build good working relationships with other team members and clients
- Will provide senior level study management
- Will balance support across a number of studies at different stages ensuring studies have the appropriate level of support at all times
- Will work independently to prioritise workload under pressure and work to changing business needs
- Will strive to improve functional and study team ways of working and share best practice across the clinical team
- Will have confidence in own abilities and know when to be assertive and diplomatic
- Will work to challenge the status quo and improve on current best practice
- Will be a Company ambassador for both internal staff and during external collaborations