Senior Clinical Project Manager

Description

The Clinical Project Manager is responsible for planning and implementing the team objectives for clinical trials and delivering to time and budget.  He/she will plan and manage the clinical trials in order to ensure the safe, effective and efficient delivery of all operational aspects of studies through all phases of study management in accordance with appropriate quality standards. He/she is accountable for the development, project management and delivery of site management plans and will work closely with clients and colleagues within the business in order to understand the requirements and deliver against these successfully.

Reporting to the Associate Director of Clinical Operations, the person in this position will work closely with the Client Key Account Manager and the Contracts and Proposals Manager in order to deliver the required services to clients.

Key Accountabilities/Responsibilities

  • Develop the initial scope of work for clinical projects, working with the client and the Aptus Clinical team to clearly define the requirements, project costs/budget and resources
  • Develop a quality management plan and associated risk log for all projects
  • Lead the resourcing of study teams and the study site set up, contributing to the study feasibility, site selection, resource plan and driving the first subject in, ongoing recruitment, risk management and study delivery plan
  • Lead the site management activities including the development and management of regulatory documentation, scheduling and management of all site visits in line with the agreed client contract requirements
  • Proactively interface with the Aptus Clinical team and the client in order to manage the project and develop solutions to issues and challenges which arise
  • Provide clinical operational expertise for the local study team and ensure compliance at all times with company governance guidelines
  • Coordinate the daily operations of the Aptus Clinical team, including definition of the project timelines with the assigned study team, coordination of the remote review of clinical data, review and approval of trip reports and follow up, management of project meetings and ensuring the provision of required training for the CRAs
  • Manage the delivery of study milestones and patient recruitment targets by the team proactively addressing deficiencies/deviations
  • Manage all project resources, including conducting regular reviews of budgets, ongoing monitoring of costs and potential overruns and the implementation of proposals for cost-effective solutions/mitigation strategies as required
  • Ensure any potential out of scope activities are tracked and discussed with the Contracts and Proposal Manager on a monthly basis
  • Work with the Associate Director for Clinical Operations to define and manage the performance of the CRA’s and CTA’s as required, providing coaching and supporting the development of clear expectations and goals to ensure team performance overall is fully optimised
  • Ensure all project documentation is managed appropriately and prepare for audit responses as required.  Prepare weekly/monthly report information for the clients
  • Develop and maintain strong, positive relationships with clients and key internal stakeholders to clearly understand the business processes and the short and long term business objectives
  • Support CRAs in site data collection and locking, query resolution, progress to data base lock
  • Support CRAs or if necessary personally undertake study start up activities by obtaining documents for drug release and ensuring site documentation is correct
  • Participate in the analysis, summary and reporting of clinical data for regulatory or market purposes as required
  • Collaborate in the preparation of quality/compliance reviews, internal audits and regulatory inspections and ensure adequate and timely CAPA follow up
  • Identify areas of best practice and contribute to activities to improve and maintain the quality and effectiveness of processes and activities across the teams
  • Maintain knowledge of all relevant clinical processes and SOPs to ensure appropriate compliance to ICH-GCP and ABPI code of practice
  • Organise, conduct and report local quality control activities with CRAs (e.g. accompanied visits, review of monitoring visit reports, review of monitoring quality, review of SMF and ISF documents and key system checks)
  • Manage and control allocated budget spend for the areas of responsibilities within this role
  • Develop, implement and maintain company policies for which you are the named Subject Matter Expert
  • Contribute to proposal generation and participation in bid defence meetings

Minimum Requirements – Education and Experience

  • Degree or equivalent qualification
  • Advanced knowledge of good clinical practice and understanding of local Competent Authority regulations is required; international clinical trial experience and knowledge of other country requirements is preferred
  • A minimum of 10 years’ clinical study management experience in biopharmaceutical industry including a minimum of 5 years in oncology and 2 years as a clinical study lead/project manager is required; global clinical trial experience is highly preferred
  • Proven ability to influence and manage both clients and investigators.
  • Ability to lead and influence in a fast paced and collaborative environment
  • Excellent interpersonal, negotiation and conflict resolution skills
  • Proven ability to lead projects and motivate at all levels
  • Ability to manage and develop others
  • Ability to work within and lead teams
  • Ability to contract with others
  • Ability to build teams and bring stakeholders together
  • Ability to lead and facilitate groups and workshops
  • Can operate on the big picture as well as with detail
  • Excellent presentation skills, with solid oral and written communication capabilities
  • Strong technical skills using PowerPoint, Excel and Word

Leadership:

 Strategic thinking

  • Ability to Act decisively
  • Motivating performance
  • Working collaboratively
  • Coaching and developing others

 Enabling:

 Business Awareness

  • Business Relationship Management
  • Influencing
  • Initiative
  • Innovation