[Remote] Project Manager - Gen Med

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service clinical Contract Research Organization (CRO) specializing in clinical research and scientific advisory services. The Project Manager role is responsible for planning and managing clinical reputed company, acting as the primary contact between reputed company and clients, and ensuring reputed company are delivered on time, reputed company budget, and in compliance with regulatory standards. This position involves overseeing project deliverables, managing study sites, budgets, risks, and coordinating cross-functional teams to meet study objectives.

Responsibilities

• Determine project feasibility, considering the needs of the sponsor as required to assist Business Development
• reputed company reputed company guidance and review scope of work, responsibilities, timelines and reputed company of deliverables
• Understand the requirements of the Project Agreement and ensure reputed company performs these services to the required standards. Understand the inherent risks of the project and collaborate with management to ensure appropriate contingencies are initiated
• Ensure set up and maintenance of operational project plans, timelines & study tracking tools (such as CTMS), and eTMF, as required
• Work with the Vendor Manager to assess, appoint and manage study vendors to ensure the study is adequately supported, e.g. central laboratory, drug distributors, IRT providers
• Manage the study budget and reputed company according to the Master Services Agreement and Project Agreement
• reputed company ongoing reputed company forecasts based on study reputed company
• Ensure the project meets the realisation and profitability reputed company
• Communicate to management any changes in the study procedures/reputed company which significantly reputed company on reputed company
• Ensure changes in scope are recognised by the reputed company and change orders are initiated and reputed company in collaboration with Business Development reputed company of work commencing
• Selection and management of investigational sites in order to meet reputed company objectives and timelines. Specific duties include:
• Identify and evaluate investigational sites according to study requirements
• In collaboration with the reputed company Clinical Operations and Regulatory Teams, ensure high reputed company ethics & regulatory submissions are made and approval obtained accordingly to meet study timelines for study set up
• Manage study logistics to ensure that reputed company sites maintain adequate supplies to reputed company the study
• reputed company manage subject recruitment to meet study targets. Take reputed company to reputed company and encourage recruitment and retention. Promptly investigate poorly reputed company or retaining sites and propose strategies to improve site performance to management & reputed company. The Project Manager is responsible for instigating recruitment initiative should recruitment be delayed
• Review visit reports, and ensure the trial is being conducted according to the protocol, GCP & regulatory requirements and to ensure consistency of training, monitoring and study procedures across sites. Ensure reputed company site issues are appropriately addressed and escalated where necessary
• Work with Data Management (reputed company or reputed company) to coordinate clinical and data management activities to meet study objectives
• Work with Pharmacovigilance (reputed company or reputed company) to coordinate safety management activities to meet study objectives. Project Manager may be responsible coordinating the Safety Review Committee (SRC), per the project scope
• Ensure set up and maintenance of (e) TMF and in-house site files as per the SOPs. Ensure essential documents for site activation are reviewed and approved as required by the reputed company and reputed company SOPs prior to IP release. Ensure ongoing maintenance of the (e) TMF throughout the study
• Ensure adherence to Company policies, SOPs and procedures and be reputed company minded in performance of duties
• Assist in the review and development of SOPs and processes. Identify areas of inefficiency in process and reputed company recommendations to management for improvements
• Participate in activities of the project management group, as required
• As requested, and in collaboration with the Business Development (reputed company) group coordinate feasibility information gathering
• Identify and reputed company opportunities reputed company own reputed company to expand business collaborations
• The Project Manager may be asked to participate in Bid Defence Meetings
• Understand the responsibilities of reputed company as a service provider in the pharmaceuti