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Clinical Project Manager
Custom Search, Minneapolis, Minnesota, United States, 55400
Our small, well-funded start-up client is adding a Clinical Project Manager to the team. The Clinical Project Manager will report to the VP Clinical (lives in MN) and will be a remote role with minimal travel. The Clinical Project Manager leads the planning, development and execution of the clinical research trial(s). Ensures compliance to study protocol, Good Clinical Practices, applicable domestic and international regulatory standards, and Standard Operating Procedures. The Clinical Project Manager will participate in development of Standard Operating Procedures, selection and implementation of systems (eTMF, EDC) to support timely reporting of data for senior management. Participates in the preparation of regulatory submissions. Has established a high degree of competence in clinical research and has experience in all aspects of a clinical research program. Functions independently with a significant degree of autonomy.
Your role with the company:
Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with regulatory policies, Good Clinical Practices, procedures and/or guidelines during clinical trials.Oversee the planning and execution of all phase of clinical studies to ensure that deliverables are completed on time and within budget.Develop an understanding of competitive landscapes for assigned products and therapeutic areas.Develop and execute project plan, manage study time and ensure activities are conducted in order to achieve
scheduled milestones and goals.Manage and direct consultants/contractors, contract research organizations to ensure that deliverables are completed
on-time, within budget, and are consistent with the scope of work.Select and Implement clinical systems (eTMF, EDC)Develop and execute enrollment plan(s).Develop and manage study related documents and materials such as investigational plans, case report forms, study
manuals, monitoring plan, informed consents, recruitment materials, clinicaltrials.gov, and other study related tools.Obtain and reviews all required essential documents necessary for study initiation.Prepare and present project progress reports to keep management and team informed.Assist with data analysis and interpretation of the results.Coordinate the development of clinical abstracts/manuscripts and presentations.Prepare the clinical sections of regulatory submissions and assist regulatory in preparing responses to regulatory
agencies' questions regarding the clinical study.Participate in presentation of clinical information to the FDA.Plan investigator and coordinator meetings and prepare and present meeting materials.Functions independently in the field and interacts with all levels of medical and scientific professionals.Suggests and implements improvements for increased departmental efficiency.Develops management and supervisory skills necessary for advancement.Assumes responsibilities of the department manager in their absence.Desired Profile:
B.S. degree in Biology, Chemistry, Nursing or related discipline and a minimum of 8+ years of related work experienceKnowledge of aortic arch anatomy, stent grafts and current practices and procedures is desired. Must have
class 3 cardiac device experience.Minimal travel, up to 10%Strong knowledge of FDA guidelines and regulations governing conduct of clinical trialsPMA
and Post Market study experience desiredDemonstrated ability to work independently and generate solutions to a wide range of difficult issuesPossesses negotiation, diplomacy, team leadership skills and organizational abilityStrong organizational skills and attention to detailAbility to handle multiple and shifting priorities in a fast-paced environment
Your role with the company:
Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with regulatory policies, Good Clinical Practices, procedures and/or guidelines during clinical trials.Oversee the planning and execution of all phase of clinical studies to ensure that deliverables are completed on time and within budget.Develop an understanding of competitive landscapes for assigned products and therapeutic areas.Develop and execute project plan, manage study time and ensure activities are conducted in order to achieve
scheduled milestones and goals.Manage and direct consultants/contractors, contract research organizations to ensure that deliverables are completed
on-time, within budget, and are consistent with the scope of work.Select and Implement clinical systems (eTMF, EDC)Develop and execute enrollment plan(s).Develop and manage study related documents and materials such as investigational plans, case report forms, study
manuals, monitoring plan, informed consents, recruitment materials, clinicaltrials.gov, and other study related tools.Obtain and reviews all required essential documents necessary for study initiation.Prepare and present project progress reports to keep management and team informed.Assist with data analysis and interpretation of the results.Coordinate the development of clinical abstracts/manuscripts and presentations.Prepare the clinical sections of regulatory submissions and assist regulatory in preparing responses to regulatory
agencies' questions regarding the clinical study.Participate in presentation of clinical information to the FDA.Plan investigator and coordinator meetings and prepare and present meeting materials.Functions independently in the field and interacts with all levels of medical and scientific professionals.Suggests and implements improvements for increased departmental efficiency.Develops management and supervisory skills necessary for advancement.Assumes responsibilities of the department manager in their absence.Desired Profile:
B.S. degree in Biology, Chemistry, Nursing or related discipline and a minimum of 8+ years of related work experienceKnowledge of aortic arch anatomy, stent grafts and current practices and procedures is desired. Must have
class 3 cardiac device experience.Minimal travel, up to 10%Strong knowledge of FDA guidelines and regulations governing conduct of clinical trialsPMA
and Post Market study experience desiredDemonstrated ability to work independently and generate solutions to a wide range of difficult issuesPossesses negotiation, diplomacy, team leadership skills and organizational abilityStrong organizational skills and attention to detailAbility to handle multiple and shifting priorities in a fast-paced environment