Clinical Project Manager - Ophthalmology
Apply NowCompany: Catalyst Clinical Research
Location: Lexington, SC 29072
Description:
Job Description
Our client is seeking a Clinical Project Manager to work onsite in their Lexington MA offices(occasional work from home). This is a permanent position. Responsible for the delivery of projects within scope, timelines, budget and quality standards; ensuring compliance with protocol, relevant Standard Operating Procedures (SOPs), applicable guidelines and regulations. To lead the project team throughout the entire project and have regular contact with the team and the sponsor. To continually assess and manage project risk and to report status to sponsor and management. Responsibilities: Have a thorough knowledge of and manage the delivery of projects within scope, timelines, budget and quality. Carry out project management tasks according to the scope of the assigned study(ies) and SOPs using the appropriate tools. Establish and maintain key interactions with stakeholders and act as the primary project contact. Have full awareness and manage terms of the project contract, budget, scope and responsibilities. Identify and escalate any out of scope activities. Provide review and input to study budgets. Notify management if additional tasks and /or resource are needed to deliver the project according to timelines and quality standards. Raise, in collaboration with the contracts department, contract and budget change order documents as required. Ensure relevant team members are aware of the scope of responsibilities. Coordinate all project tasks and team members including internal resource from all functions and external vendors. Forecast, track and report status to Management. Attend and prepare information for monthly project finance meeting for assigned studies. Attend and prepare status report for monthly project review meeting for assigned studies. Have an appropriate understanding of the product, protocol and therapeutic area to be able to advise and discuss with the project team members and study site personnel. Ensure the project team is appropriately trained and, if required, recommend additional training requirements to the Project Director. Manage the quality processes and plans to ensure compliance with relevant SOPs, regulations and quality standards. Plan and lead activities associated with audits in liaison with QA and contribute to Regulatory Inspections as required Anticipate, identify, assess and manage risks to project. Recommend, implement contingency and risk mitigation plans. Represent the company at meetings and conferences. Provide input into proposals for prospective studies and represent the company at meetings with potential clients. Assist with feasibility studies. Work with the Project Management team to help develop and implement process improvements and share best practice. Provide performance feedback on project team members to the individual and their respective line managers Attend and actively participate in Project Management group meetings and training. Remain up to date with all relevant training, SOPs and applicable regulatory requirements. Provide mentorship and training of clinical operations staff. Provide input and participate in process improvement efforts as required.
Experience Required
BS or equivalent experience. At least 8 years of Clinical Project Management experience in multiple phases of studies. Ophthalmology experience a strong plus.
Our client is seeking a Clinical Project Manager to work onsite in their Lexington MA offices(occasional work from home). This is a permanent position. Responsible for the delivery of projects within scope, timelines, budget and quality standards; ensuring compliance with protocol, relevant Standard Operating Procedures (SOPs), applicable guidelines and regulations. To lead the project team throughout the entire project and have regular contact with the team and the sponsor. To continually assess and manage project risk and to report status to sponsor and management. Responsibilities: Have a thorough knowledge of and manage the delivery of projects within scope, timelines, budget and quality. Carry out project management tasks according to the scope of the assigned study(ies) and SOPs using the appropriate tools. Establish and maintain key interactions with stakeholders and act as the primary project contact. Have full awareness and manage terms of the project contract, budget, scope and responsibilities. Identify and escalate any out of scope activities. Provide review and input to study budgets. Notify management if additional tasks and /or resource are needed to deliver the project according to timelines and quality standards. Raise, in collaboration with the contracts department, contract and budget change order documents as required. Ensure relevant team members are aware of the scope of responsibilities. Coordinate all project tasks and team members including internal resource from all functions and external vendors. Forecast, track and report status to Management. Attend and prepare information for monthly project finance meeting for assigned studies. Attend and prepare status report for monthly project review meeting for assigned studies. Have an appropriate understanding of the product, protocol and therapeutic area to be able to advise and discuss with the project team members and study site personnel. Ensure the project team is appropriately trained and, if required, recommend additional training requirements to the Project Director. Manage the quality processes and plans to ensure compliance with relevant SOPs, regulations and quality standards. Plan and lead activities associated with audits in liaison with QA and contribute to Regulatory Inspections as required Anticipate, identify, assess and manage risks to project. Recommend, implement contingency and risk mitigation plans. Represent the company at meetings and conferences. Provide input into proposals for prospective studies and represent the company at meetings with potential clients. Assist with feasibility studies. Work with the Project Management team to help develop and implement process improvements and share best practice. Provide performance feedback on project team members to the individual and their respective line managers Attend and actively participate in Project Management group meetings and training. Remain up to date with all relevant training, SOPs and applicable regulatory requirements. Provide mentorship and training of clinical operations staff. Provide input and participate in process improvement efforts as required.
Experience Required
BS or equivalent experience. At least 8 years of Clinical Project Management experience in multiple phases of studies. Ophthalmology experience a strong plus.