project manager
4 the last 166 days, recently 2023-04-21
Responsibility
- lead the development and execution of key programs
- ensure the PMO's strategy, responsibilities, services, and deliverables are successfully implemented
- monitoring and assisting the team with reporting to Project Sponsors and stakeholders
Show more +40 - develop necessary documents, study plans and training resources
- handle the ethics, regulatory needs and local applications
- provide regular updates to Senior Management on project requirements and activities
- develop project management frameworks and standards
- communicate with external customers such as steering committees, investigators, study nurses and clinical trial pharmacists etc
- coordinate activities for the launch of new products with external third parties
- compile and manage financial and KPI reports related to projects
- you will attend and partake in investigator meetings
- troubleshoot projects and escalate key issues and updates in a timely manner
- ensure the project's capacity planning and resource tracking are maintained
- accountable for developing, setting up, and upholding trial master fields/site files
- guarantee that site and outsourced CRO personnel are trained in protocol specific processes
- assist a cross-functional team in providing R&D/LCM programmes on time and to the required standard
- ensure that the Risk Log, Action Log, Decisions Log, and Issue Register are regularly updated and maintained
- offer daily operational management of CROs and suppliers guaranteeing delivery against contracted scope of work for the assigned location
- create Business Cases for pitching and initiating new R&D, medical, and clinical programs
- make sure cross-project dependencies are appropriately managed and dependency logs are accurate
- plan site agreements, contracts, and financial/site payment tracking throughout study performance
- review the business's costs, benefits, risks, and timelines with senior management and secure appropriate sponsorship
- ensure that good practices are distilled and lessons learned are recorded at the end of each project
- for this position, you will manage the recruiting sites and vendors such as CROs, labs, etc, to guarantee performance expectations are met
- support the planning of research ethics committee and regulatory authority approval
- for this role, you will be responsible for status of study/ies discussed consistently with study team management and that unresolved problems are raised when suitable
- ensure all project-related action items are closed on time and to a high standard by managing project plans and organizing meetings with stakeholders
- ensure that operational processes are in place and functional to support future business plans
- encourage team cohesion and quality work from the team
- any other assigned duties
- accountable for protocols developed in concurrence with COO and investigators
- conduct site visits to enable study set up and instigation, routine supervising visits throughout patient recruitment, as well as close out visits on study completion
- make sure projects/programs are aligned, coordinated, and visible to senior leadership
- establish and embed a governance and control system for the project
- the ideal candidate will collaborate with the CRO and site personnel to guarantee precise data gathering, supervising data quality and accomplishment in a timely manner
- ensure all work is completed in accordance with the company's values and with the highest ethics
- plan, manage milestones, define project scope and forecast resources
- responsible for project management of the trial, cooperating with the director of clinical operations and any other shareholders to guarantee milestones are met and the trial is delivered within budget in a timely manner
- develop, commercialize, manufacture, or support other business-related programs as needed
- manage change across the project
- manage developing and executing a trial supervising plan to guarantee high quality trial conduct, using a combination of central supervising and site visits, suitable to the trial
- keep the project team and organization leadership informed of the status of the project on a regular basis
- the ideal candidate will manage study oversight and status documenting study goals communicated and approved, which involved the development of study deadlines, communication, risk and quality plans, team training and oversight
Requirements
- applicants must hold a degree in a relevant scientific discipline
- applicants must be eligible to work in the United Kingdom
- familiarity in a clinical trials project management and leadership role
Show more +47 - an accredited project management qualification
- experience managing project teams or PMOs for at least 10 years
- comprehension of statutory clinical trial guidelines, ICH-GCP and research governance needs
- educated to a degree level in a life science or similar discipline
- an ability to coordinate both internal and external programs
- ability to plan, execute, control, and close a project with minimal supervision and to manage multiple project components simultaneously
- an organised and analytical individual with a high attention to detail
- project management abilities
- ability to communicate across functional lines and interact effectively with others
- extensive experience directing complex programs in the pharmaceutical/biopharmaceutical industry
- an understanding of the management of a PMO
- practitioner of PRINCE2, PMP, or equivalent project management qualification
- A lateral thinker
- familiarity with developing trial-connected papers such as necessary documents and plans, as well as plan multifaceted reports
- presentation, interpersonal and communication skills both verbally and in writing
- possess cost and financial acumens
- an expert in the biological or pharmaceutical field
- working experience as a manager or leader in a team
- prior involvement in performing on-site training and supervising visits
- capable of developing and updated working techniques
- skill in creating project plans and identifying critical path items
- an understanding of how to manage a project's lifecycle with teams of five to twenty-five employees
- interpersonal and communication skills both verbally and in writing
- an organised individual with a high attention to detail
- knowledge of technical aspects
- the ability to understand and work with cGxP, quality standards, clinical requirements, regulatory requirements, and manufacturing requirements for commercial products
- an understanding of AGILE or PRINCE2 methodology
- comfortable in a small, energetic organisation
- comprehension of the cross-functional needs for trial set-up and distribution
- works well in a team
- acquaintance supervising outsourced CRO work
- ability to analyze complex technical situations and identify areas for improvement, followed by leading and implementing improvements
- ability to develop and maintain project and program plans, including risk assessments, actions, issues, and dependencies
- able to adjust workload and change priorities based on company needs
- deliberation capabilities
- comprehension of cardiovascular disease and treatment
- ability to build and manage multi-skilled teams effectively
- skills in Planning resources and assigning tasks efficiently
- educated to a degree level in a clinical research discipline with the ability to successfully set-up and accomplish trials in a clinical trial manager and/or project manager role
- ability to identify, build, and secure sponsorship for new programs
- knowledge of dependency mapping, resource planning, and risk management
- A demonstrated ability to plan, communicate, influence, and negotiate
- ability to communicate effectively written and orally
- have the ability to influence people at all levels
- ability to build and maintain strong relationships with key stakeholders
- competence in mediating disagreements and negotiating consensus
- understanding of how to define and deliver benefits for projects and programs
high salary - 45% higher than the average in this position
Earnings for position project manager
project manager - How much money do you make working at this position?
Average salary at company HOBSON PRIOR is 6583£.
The national average salary is 3800£.
1700 £
Lowest
Lowest
4850 £
Average
Average
8000 £
Highest
Highest
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