Clinical Project Manager
What You'll Do:
Lead, plan, implement, evaluate, and complete full execution of assigned clinical trials; frequently functions as a global trial lead; serve as a resource to others in these areas Set goals, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trial Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provides oversight of all functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities Prepare or provide oversight in the development of trial plans, timelines, schedules, resources, and budgets; lead team to provide effective solutions to challenges that arise during the clinical trial project Provide oversight and guidance in the development of trial required deliverables Serve as the client primary point of contact at project operational level; provides effective client management for trial issues and effectively escalates issues to assigned trial Director and executive management Provide oversight to contracted vendors; reviews contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations Provide oversight of appropriate project tracking using computer-assisted programs and ensures timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management Monitor ongoing resource needs to the project; keeps appropriate functional department heads apprised of any identified resource needs or performance issues Ensure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol Provide or ensure oversight of Clinical Research Associate (CRA) tasks on assigned clinical trials; provides oversight of the CRA's management of sites and monitoring of the clinical trial data.
Review and approve site trip reports in assigned geographical regions and escalates site issues as needed to assigned trial Director, CTI executive management and/or client/sponsor in accordance with the trial's Communication Plan Attend site visits on an as-needed basis to provide support to CTI and/or site staff Implement project activities according to scope of contracted work Evaluate and manage project budget against project milestones and scope and collaborate with the assigned trial Director as needed to take corrective measures where necessary to keep the project in line with budget Assess scope of work against client contractual agreements; may consult with trial-assigned Director if needed to facilitate change of scope orders when appropriate Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects Participate and provide oversight in the planning of investigator meetings; develops and/or approves meeting agendas or related materials and conducts presentations Provide oversight in the management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial's TMF Plan Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.
) Identify and provide leadership in process improvement activities and initiatives Contribute to oncology initiatives and/or center of excellence Provide leadership and is seen as a subject matter expert for other OCPM and clinical operations staff; assist in the development of reference and resource materials for OCPM Demonstrate oncology expertise through the creation of or improvement to oncology specific trackers and tools.
Contribute to development of oncology specific training materials Effectively coach and train others in OCPM practices; foster the development of clinical project coordinators (CPC) and other OCPM staff What You'll Bring:
Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience At least 8 years clinical research or related research management experience (CRO, pharmaceutical industry) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry Previous experience in a Clinical Project Manager or Trial Manager level position in oncology Graduate degree preferred Previous technical and managerial experience in hospital setting, pharmaceutical company, or CRO preferred Why CTI? We support career progression -We have a structured mentoring program to provide the support you need to move forward We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (click here to learn more about our CTI Cares program) We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%) Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market Recommended Skills Agenda Development Auditing Business Development Business Process Improvement Clinical Research Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
Lead, plan, implement, evaluate, and complete full execution of assigned clinical trials; frequently functions as a global trial lead; serve as a resource to others in these areas Set goals, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trial Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provides oversight of all functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities Prepare or provide oversight in the development of trial plans, timelines, schedules, resources, and budgets; lead team to provide effective solutions to challenges that arise during the clinical trial project Provide oversight and guidance in the development of trial required deliverables Serve as the client primary point of contact at project operational level; provides effective client management for trial issues and effectively escalates issues to assigned trial Director and executive management Provide oversight to contracted vendors; reviews contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations Provide oversight of appropriate project tracking using computer-assisted programs and ensures timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management Monitor ongoing resource needs to the project; keeps appropriate functional department heads apprised of any identified resource needs or performance issues Ensure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol Provide or ensure oversight of Clinical Research Associate (CRA) tasks on assigned clinical trials; provides oversight of the CRA's management of sites and monitoring of the clinical trial data.
Review and approve site trip reports in assigned geographical regions and escalates site issues as needed to assigned trial Director, CTI executive management and/or client/sponsor in accordance with the trial's Communication Plan Attend site visits on an as-needed basis to provide support to CTI and/or site staff Implement project activities according to scope of contracted work Evaluate and manage project budget against project milestones and scope and collaborate with the assigned trial Director as needed to take corrective measures where necessary to keep the project in line with budget Assess scope of work against client contractual agreements; may consult with trial-assigned Director if needed to facilitate change of scope orders when appropriate Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects Participate and provide oversight in the planning of investigator meetings; develops and/or approves meeting agendas or related materials and conducts presentations Provide oversight in the management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial's TMF Plan Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.
) Identify and provide leadership in process improvement activities and initiatives Contribute to oncology initiatives and/or center of excellence Provide leadership and is seen as a subject matter expert for other OCPM and clinical operations staff; assist in the development of reference and resource materials for OCPM Demonstrate oncology expertise through the creation of or improvement to oncology specific trackers and tools.
Contribute to development of oncology specific training materials Effectively coach and train others in OCPM practices; foster the development of clinical project coordinators (CPC) and other OCPM staff What You'll Bring:
Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience At least 8 years clinical research or related research management experience (CRO, pharmaceutical industry) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry Previous experience in a Clinical Project Manager or Trial Manager level position in oncology Graduate degree preferred Previous technical and managerial experience in hospital setting, pharmaceutical company, or CRO preferred Why CTI? We support career progression -We have a structured mentoring program to provide the support you need to move forward We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (click here to learn more about our CTI Cares program) We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%) Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market Recommended Skills Agenda Development Auditing Business Development Business Process Improvement Clinical Research Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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