Clinical Project Manager

The Clinical Project Manager is responsible for the management of clinical projects and studies by collaborating with Clinical Affairs in the implementation of various team and company objectives for the execution of clinical studies. The role, in close collaboration with the Project Leader, is accountable for achieving successful deliverables, working together with the clinical team while meeting company and regulatory requirements according to time, quality, scope and within budget. The position is office-based.

Responsibilities

• Proactively manage project-level operations, including but not limited to management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
• Provide project leadership and project support for both U.S. and International Clinical Trials consistent with applicable laws, regulations, guidelines and policies.
• Ensure conformance with GCP, trial protocols and trial safety reporting requirements
• Lead projects that support division and company objectives
• Adhere to study execution strategy in order to meet business objectives
• Implement immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner
• Ensures protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up
• Support IRB/EC/CA submissions and renewals
• Contribute to the strategic development of FDA submissions (510K), Premarket Approval, IDE, De Novo and Medical Device Reporting
• Oversee site contracts, payment schedules and payments
• Provide efficient and effective updates on trial progress to the Medical Director as requested
• Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.
• Ensure effective project plans are in place and operational for each trial. Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
• Attend trial progress meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner. Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.
• Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.

Qualifications

• Must have relevant experience executing clinical programs in medical devices, particularly cardiovascular interventional cardiology or ICU-based clinical trials.
• Solid understanding of reimbursement
• Education: Bachelor’s degree in Lifescience, Master in a health-related field is a plus
• Languages: proficiency in oral and written English and Italian (third language would be appreciated)
• Experience: minimum of five years of clinical research experience in Project Management, Data Management or Clinical Monitoring. Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485

Personal Skills

• Ability to communicate, problem solve and work effectively in an international team
• Innovative and self-motivated
• Good organization skills and ability to prioritize goals and responsibilities
• Ability to negotiate and communicate with clients in a professional manner
• Proficient computer skills with the ability to understand and assess technology alternatives and implication for current processes
• Ability to be productive and successful in a dynamic work environment