Precision For Medicine

Clinical Research

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction

Clinical Trial Manager / Senior Clinical Trial Manager

• We have an opportunity for an experienced Clinical Trial Manager to join our growing team.
• You will be the hub of central intelligence for the studies you will be managing and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.
• We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world.

Clinical Trial Manager – Senior

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out.
• Successful execution of assigned trials and ensuring completion of trial deliverables.
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members.
• Mentoring and training of team members.
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities.
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor

• You love having responsibility and a say in how clinical trials are run
• You plan ahead, but have alternative options and a flexible approach
• You are client focused
• You are well organised and able to manage timelines and shifting priorities, without sacrificing quality.
• You communicate clearly, often and concisely and know that your role is crucial in keeping the trial running smoothly
• You are a master at identifying any risks that threaten projects and handle them resolutely
• You thrive and work with autonomy and ownership to deliver successful outcomes

Clinical Operations

• The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.
• PM will either manage regional trials (moderate complexity) and/or supportive role in managing complex global trials.
• Serve as primary point-of-contact and primary escalation point to the client.
• Coordinate and oversee all functional services including external vendors to the established timeline and budget.
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
• Ensure functional areas are fully aware of the study scope and are managing the scope for their functional areas accordingly.
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality.
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation.
• Establish tracking metrics to monitor trial and team progress towards project goals.
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise.
• Lead both internal and client meetings and set expectations for the project team.
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project.
• Support business development and marketing activities as appropriate, including travel to Bid Defence meetings as required.
• Perform other duties as assigned by management.

Clinical Project Manager

Research Analyst

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Clinical Research Associate I

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start-up procedures including feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Clinical Research Associate

Project Manager

• You will independently lead clinical projects in accordance with the study budget and scope of work.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

Project Manager – Client Dedicated

• Independently lead clinical projects in accordance with the study budget and scope of work.
• Use strong interpersonal and organizational skills to set and achieve objectives in the execution of projects.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

Project Manager, Senior Project Manager – Client Dedicated

• You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets

• Independently lead clinical projects in accordance with the study budget and scope of work.
• Use strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives.
• Run international trials as well.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
• Liaise with Project Team and senior management of both Precision and sponsors, including C level.
• Handle and lead all aspects of a clinical research trial or trials.
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
• Prepare and review protocols and other study documentation such as project plans, inform consents, site contracts and budgets.

• Plan, direct, coordinate, and deliver activities for designated clinical study projects
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversee all functional services including external vendors
• Manage the study budget, ensuring project remains within scope
• Maintain integrated collaboration with clinical operations in the delivery of trials
• Communicate effectively with client and Precision management