Clinical Project Manager I Permanent I California, USA

My client is a medical device company specialising in treating BPH. They have used their technology on over 60,000 patients and are looking to acquire an exceptional Clinical Project Manager to join their team in order to help other patients.

The Role

The Clinical Project Manager is responsible for leadership and execution of clinical studies in support of the direction and goals of the Company. As an integral member of the Clinical Operations team, this position manages all aspects of a clinical study from study concept through site selection, start-up, and close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. In addition, this position develops and assesses SOPs, reviews processes for efficiency and compliance, and manages and mentors team members. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research and urology.

About you

Responsibilities

• Develop study protocols and associated documents as the project lead and clinical operations subject matter expert.

• Ability to lead direct reports and provide guidance in completion of required tasks and projects

• Act as the project manager of a cross-functional clinical study team including developing timelines, budgets, resources planning and risks associated with assigned projects.

• Independently manage all phases of a clinical study including essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.

• Manage study meetings to ensure completion of established project team goals and objectives.

• Oversee qualification, site initiation, interim and close-out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.

• Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution.

• Assess trends in data including adverse events, protocol violations, etc.

• Contribute to clinical reports, data management, data analysis, and publications.

• Develop and assess SOPs annually.

• Provide study status updates to Management team and develop sufficient resolution of identified action items.

• Monitor emerging trends to help integrate new requirements into department procedures.

• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.

• Participate in department systems and development initiatives, including related trainings.

• Support investigator meetings as needed.

• Maintain credentialing requirements at hospitals and clinics as needed.

• Complete projects and tasks consistent with corporate objectives.

• Support the Clinical Operations team in general and with various improvement projects.

• Perform other duties as assigned.

• Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.

• At least 8 years of clinical research experience, medical device experience preferable

• Past experience with mentoring and managing direct reports is highly desired

• US IDE and OUS experience highly preferred, post-market study experience is desirable.

• Knowledge of urology and BPH disease state or willingness to undergo rigorous and fast learning independently.

Specialized Skills / Other Requirements

• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.

• Excellent time management skills.

• Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.

• Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.

• Ability to perform at high-levels with limited supervision and effectively partner with team members when necessary.

• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.

• Proficient in Microsoft Word, Excel, and Access and the ability to quickly learn other software tools and applications.

• Ability to develop strong relationships with investigative sites.

• Ability to travel approximately 50% to perform training and monitoring.

• Valid driver’s license issued by the state in which the individual resides

Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.

Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything

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