Clinical Project Manager

Clinical Project Manager
Our client biopharmaceutical organisation is recruiting for a Clinical Project Manager to join their team. As Clinical Project Manager you will coordinate the day-to-day management of the clinical operations activities of the organisation. Remote working with the ability to be in the Dublin office bi monthy is an option for this role.

Responsibilities

• Provides direction to the Clinical Development Team (CDT)
• Develop and maintain effective working relationships with other CDT members
• Ensures that each CDT member is aware of his/her specific area of responsibility, contribution to, and participation in the CDT
• Contribute to the development of the study timelines, resources, budget, risk, and quality plans
• Accountable for meeting or exceeding goals for clinical trial operations for development projects
• Ensure all operational tracking needs are identified to meet the needs of the team and facilitate reporting to the Managing Director or authorized representative of the Managing Director
• Ensures the maintenance, tracking, and accuracy of operational data and milestones
• Set up and maintain archives for essential documents including Trial Master File, ensuring inspection-readiness
• Develop or provide operational input to the development of study documents, including study protocols and Investigator’s Brochure
• Oversee the collation of feedback on study level documentation from the CDT and ensures appropriate updates are made
• Provide input into, and implementation of, the study level audit plan, quality, risk management and contingency plans
• Maintain study drug requirements and oversees the global drug supplies level
• Keeps up to date with country/regional regulatory requirements
• Deliver the operational elements of the study plan
• Accountable for ensuring site initiation and maintenance activities with the focus on contracts and budgets that comply with local/regional requirements, data privacy requirements and quality standards
• Regularly communicate the study status and timelines and escalates unresolved issues appropriately to the Managing Director or authorized representative of the Managing Director
• Chair CDT meetings, and contribute to the organization of Investigator meetings, monitor workshops, CRO kick-off meetings
• Proactively manages actual recruitment versus planned patient recruitment status, communicates variance to, and implements contingencies in consultation with the Managing Director or authorized representative of the Managing Director.
• Ensures the completion of any corrective action plans resulting from site audits
• Coordinates responses to study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented
• Oversees the timely supply of all materials (from internal and external parties) to sites and CRO/vendors
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Provides operational input into the selection of CRO/CRO partners and contract negotiation under the direction of the Managing Director or authorized representative of the Managing Director
• Primary day-to-day contact for operational-related activities where appropriate
• Oversees the reconciliation of invoices against scope of work and completed activities

• University Degree related to Life Sciences (e.g., human biology, biochemistry, biology, pharmaceutical science, medical doctor, veterinary medicine, chemistry, engineer).
• Proven clinical operations experience in a pharmaceutical and/or biotech company of at least 4 years in project management of operational aspects of clinical studies, including development of timelines, budgets and resource plans in complete and/or partially outsourced settings
• Experience across a range of therapeutic areas, experience in psychiatry and/or neurology is a benefit
• Experience of leading clinical trial teams, working with vendors (CROs, IVRS, central laboratories)
• Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
• Updated knowledge of ICH GCP requirements
• Self-driven and motivated team player
• Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
• Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
• Good organization and tracking skills, as well as attention to detail
• Mandatory fluent English (both oral and written) – other languages are an asset