Late-Phase Clinical Trials Sr Project Manager - Remote USA!
Company Name:
Mapi, Inc
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
Mapi is adding a Sr Project Manager to our current Clinical Research Project Management team in Lexington, KY, or Remote USA! With your College Degree, and a minimum of six years' project management experience in a clinical trials organization, we want to talk to you today! This position may be worked remotely if needed.
Summary
The Project Manager is responsible for the overall coordination and management of domestic and/or global Phase IIIb-IV, registry, or compliance programs; leading large project teams through all phases of project development in accordance with GCPs and MAPI SOPs. May provide assistance with preparation and presentation of marketing proposals; training to the project team as appropriate, and provides management and mentoring to less experienced team members. Manages complex, multifaceted programs in terms of customer, therapeutic area or time/quality/cost parameters of deliverables. Oversees all functional areas involved in delivery of various aspects of clinical programs while meeting client's needs and adhering to the contracts and associated project budgets. Typically responsible for management of more than one project.
Responsibilities and Accountabilities
Responsible for managing, leading and motivating the assigned cross-functional project team, facilitating the team's ability to fulfill their responsibilities in accordance with project contracts, contract amendments and MAPI policies, procedures and SOPs.
Responsible for developing and maintaining a close working relationship with client's study management teams to ensure client satisfaction, operational and customer service excellence.
Responsible for the successful design, implementation, tracking and maintenance of project plans for assigned projects.
Responsible for strategic aspects of assigned studies including oversight of day-to-day project operations and third party vendor activities.
Responsible for proactively tracking budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow-up on change in scope/contract/work order amendment activities.
Responsible for working with MAPI functional department leads, determine and manage project resource needs and utilization according to project contract/work order and contract/work order amendments.
Responsible for working with functional areas and Finance to determine appropriate revenue forecasting and revenue recognition based on project plan, budget and contract deliverables.
Responsible for planning, participating and presenting at investigator meetings, client meetings and project team meetings and training as required.
Responsible for being accountable for developing and maintaining project metrics, timelines, and deliverables.
Responsible for ensuring project documentation is complete, current, stored appropriately and audit-ready.
Responsible for proactively communicating to appropriate MAPI management, client and third party vendors as warranted about project progress, potential issues and appropriate recommendations for resolution.
Qualifications:
Education: BS/BA four (4) year degree preferably in science, nursing or healthcare field (or equivalent experience). Advanced degree in medical/pharmaceutical discipline, project management or business is preferred.
Work
Experience: Six (6) years clinical trials experience including at least six (6) years Project Management experience in a CRO, pharmaceutical, device or biotechnology setting. Late Phase Global or Clinical Trial experience is required.
Knowledge/Skills/Attributes:
Excellent written and verbal communication skills.
Thorough knowledge of GCP and ICH Guidelines, and understanding of Good Epidemiological Practices.
Effective organizational, analytical, and time management skills.
Strategic thinker who is highly adaptable with mature business judgment.
Thorough knowledge of financial management (budget development, cost accounting, forecasting, margins, profit and loss, invoicing, etc.)
Demonstrated ability to work well within a matrix environment; able to provide leadership, facilitate teamwork, communication, and optimize team productivity.
Professional liaison skills for developing and maintaining successful partnership relationship with client.
Demonstrated ability to lead by example and successfully motivate and direct cross functional, culturally diverse projects and project teams.
Excellent problem solving, judgment and decision making skills with the ability to motivate staff to seek creative solutions to issues surrounding on-time, on-budget and quality study delivery.
Demonstrated ability to handle challenging situations, multiple tasks and conflicting deliverables while maintaining motivation of teams across numerous projects.
Experience navigating MS Project, Excel and MS Office.
Certification/License: RN, BSN, MSN
Click here to apply: http://mapigroup.com/careers/late-phase-clinical-trials-sr-project-manager-remote-usa/
As an Equal Opportunity Employer, we are committed to a diverse work force.Estimated Salary: $20 to $28 per hour based on qualifications.
Mapi, Inc
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
Mapi is adding a Sr Project Manager to our current Clinical Research Project Management team in Lexington, KY, or Remote USA! With your College Degree, and a minimum of six years' project management experience in a clinical trials organization, we want to talk to you today! This position may be worked remotely if needed.
Summary
The Project Manager is responsible for the overall coordination and management of domestic and/or global Phase IIIb-IV, registry, or compliance programs; leading large project teams through all phases of project development in accordance with GCPs and MAPI SOPs. May provide assistance with preparation and presentation of marketing proposals; training to the project team as appropriate, and provides management and mentoring to less experienced team members. Manages complex, multifaceted programs in terms of customer, therapeutic area or time/quality/cost parameters of deliverables. Oversees all functional areas involved in delivery of various aspects of clinical programs while meeting client's needs and adhering to the contracts and associated project budgets. Typically responsible for management of more than one project.
Responsibilities and Accountabilities
Responsible for managing, leading and motivating the assigned cross-functional project team, facilitating the team's ability to fulfill their responsibilities in accordance with project contracts, contract amendments and MAPI policies, procedures and SOPs.
Responsible for developing and maintaining a close working relationship with client's study management teams to ensure client satisfaction, operational and customer service excellence.
Responsible for the successful design, implementation, tracking and maintenance of project plans for assigned projects.
Responsible for strategic aspects of assigned studies including oversight of day-to-day project operations and third party vendor activities.
Responsible for proactively tracking budget and scope changes, obtaining necessary client approvals for change in scope of work. Initiate and follow-up on change in scope/contract/work order amendment activities.
Responsible for working with MAPI functional department leads, determine and manage project resource needs and utilization according to project contract/work order and contract/work order amendments.
Responsible for working with functional areas and Finance to determine appropriate revenue forecasting and revenue recognition based on project plan, budget and contract deliverables.
Responsible for planning, participating and presenting at investigator meetings, client meetings and project team meetings and training as required.
Responsible for being accountable for developing and maintaining project metrics, timelines, and deliverables.
Responsible for ensuring project documentation is complete, current, stored appropriately and audit-ready.
Responsible for proactively communicating to appropriate MAPI management, client and third party vendors as warranted about project progress, potential issues and appropriate recommendations for resolution.
Qualifications:
Education: BS/BA four (4) year degree preferably in science, nursing or healthcare field (or equivalent experience). Advanced degree in medical/pharmaceutical discipline, project management or business is preferred.
Work
Experience: Six (6) years clinical trials experience including at least six (6) years Project Management experience in a CRO, pharmaceutical, device or biotechnology setting. Late Phase Global or Clinical Trial experience is required.
Knowledge/Skills/Attributes:
Excellent written and verbal communication skills.
Thorough knowledge of GCP and ICH Guidelines, and understanding of Good Epidemiological Practices.
Effective organizational, analytical, and time management skills.
Strategic thinker who is highly adaptable with mature business judgment.
Thorough knowledge of financial management (budget development, cost accounting, forecasting, margins, profit and loss, invoicing, etc.)
Demonstrated ability to work well within a matrix environment; able to provide leadership, facilitate teamwork, communication, and optimize team productivity.
Professional liaison skills for developing and maintaining successful partnership relationship with client.
Demonstrated ability to lead by example and successfully motivate and direct cross functional, culturally diverse projects and project teams.
Excellent problem solving, judgment and decision making skills with the ability to motivate staff to seek creative solutions to issues surrounding on-time, on-budget and quality study delivery.
Demonstrated ability to handle challenging situations, multiple tasks and conflicting deliverables while maintaining motivation of teams across numerous projects.
Experience navigating MS Project, Excel and MS Office.
Certification/License: RN, BSN, MSN
Click here to apply: http://mapigroup.com/careers/late-phase-clinical-trials-sr-project-manager-remote-usa/
As an Equal Opportunity Employer, we are committed to a diverse work force.Estimated Salary: $20 to $28 per hour based on qualifications.
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