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ICONMA, LLC Clinical Trials Project Manager in United States

Clinical Trials Project Manager Location: Remote Duration: 6 Months Description: Education & Experience Type of Experience BA/BS + at least 2 years OR High School/GED + at least 5 years clinical research and project management experience The Clinical Trials Project Manager will be responsible to oversee and manage clinical trials with biopharmaceutical companies (Sponsor) including participating in the pre-sales, contracting, and ensuring the clinical trial meets contractual requirements in accordance with SOPs, policies, and practices. The role of the Clinical Trial Project Management team is focused on project delivery, productivity, and quality to ensure strong customer and patient satisfaction for clinical trials. Lead and coordinates project activities and leads completion of deliverables in alignment with overall program strategy considering impact to risks/risk mitigation, budget, effort estimates and schedule Serve as the point of contact for the Sponsor and other functional team members for the assigned clinical trial project Participate in bid defense preparations. Lead bid defense presentations in partnership with the Business development team Lead activities across numerous functions to meet the objectives of a given program including scope, budget, and schedule Establish and maintain project documentation and procedures Develop risk mitigation plans including appropriate communication and escalation plans to mitigate risk Collaborates closely with other core team leaders within the Clinical Trials business Demonstrates the ability to proactively identify solutions to improve existing business processes Understands and maintains compliance with internal and external privacy and legal Manage the project finances in accordance with the customer contract and the budget; Work closely with the Director of Finance, RWE Clinical Trials Identify changes in scope and manage the change control process, as necessary Bachelor’s degree in Life Sciences or related field and at least 2 years of clinical research and project management experience Experience collaborating with others to deliver results to meet timeline, metrics and budget. Knowledge of the use of RWE for clinical trials Knowledge of EDC systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in clinical trials. Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (ie. GCP and ICH guidelines) Experience utilizing a results-oriented to delivery Knowledge of project finances including experience managing, contractual obligations and implications Experience organizing resources needed to complete tasks, set objectives , and provide clear direction to other team members As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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