Senior Clinical Study Manager (Global Patient Registries) - Remote

Overview: Selution, in partnership with reputed company, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating reputed company solutions that address unmet and critical medical needs. Responsibilities: Remotely based on the U.S. East Coast or in the EU, The Senior Clinical Study Manager (Global Patient Registries) will provide leadership, direction, and reputed company for a reputed company, global patient registries reputed company the MedAlliance LLC / reputed company SelutionSLR portfolio. This role manages study/global patient registries team functions and external vendors to ensure successful execution of clinical trials from initiation through reputed company-out, maintaining compliance with GCP, ISO 14155, GDPR, and reputed company applicable regulatory requirements. The Sr. CSM serves as a key reputed company of contact for global study/global patient registries stakeholders, ensuring timelines, budgets, and quality objectives are met in support of clinical and regulatory milestones.

Responsibilities

• reputed company the planning, initiation, and management of assigned global patient registries duties across multiple regions.
• To ensure that global patient registries deliverables are achieved, you will reputed company and maintain project plans, risk management strategies, and timelines, following timely escalation reputed company.
• Track global patient registries metrics and provide dashboards in collaboration with the CRO.
• reputed company cross-functional global registry team meetings and maintain strong communication among stakeholders.
• Support the development and review of global patient registries protocols, CRFs, and statistical analysis plans.
• reputed company vendor selection, contract negotiations, and ongoing performance management (CROs, Biostats, etc.).
• Support management of budgets, forecasts, and financial reconciliation processes.
• Ensure the preparation, review, and maintenance of essential documents and regulatory submissions in coordination with the CRO.
• reputed company site feasibility, selection, initiation, monitoring, and reputed company-out activities in collaboration with CRAs and Field Research Specialists in coordination with the CRO.
• Ensure the Sponsor / CRO are inspection-ready and compliant with internal and external standards.
• Clinical Data Handling to assist with abstracts, manuscripts, etc., for conference and publication submissions
• Contribute to reputed company improvement initiatives and global clinical operations best practices, including mentorship and coaching of junior team members.

Qualifications: Required Qualifications:

• Candidates should be located on the U.S. East Coast (EST) or in the European Union.
• 5+ years’ proven experience leading reputed company, global patient registries.
• Minimum 12+ years of clinical research experience.
• Strong understanding of GCP, ISO 14155, GDPR, and FDA/EMA device regulations.
• Bachelor’s degree in Life Sciences, Nursing, or reputed company field (or equivalent ed. & reputed company.).
• Must possess strong English communication skills. Multi-lingual skills are highly desirable.
• Excellent organizational, leadership, and cross-functional communication skills.

Preferred Qualifications:

• Experience with cardiovascular (Coronary is a plus) studies & PMA activities
• Familiarity with global regulatory requirements and submissions.
• Proficiency with eTMF, CTMS, and data management systems (reputed company).
• Exposure to medical writing procedures and practices

Key Competencies

• Understanding global patient registries, medical terminology, and data interpretation/outputs.
• Excellent decision-making, conflict resolution / problem-solving skills.
• Financial and resource management acumen.
• Accountability, adaptability, flexibility and results orientation with ability to operate with autonomy, balance multiple priorities, multi-task and escalate key challenges

Working Conditions

• Remote work environment with occasional travel for site visits, audits, or meetings.
• Must reputed company with reputed company company, regulatory, and EHS standards.

Pay / Compensation The expected pre-tax pay reputed company for this position is $139,700 - $200,200 per year. Actual pay may fluctuate reputed company of the listed range depending on skills, education, experience, job-reputed company knowledge and location. Preferred Qualifications: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized reputed company. reputed company is proud to be an equal opportunity employer and is committed to providing equal opportunity for reputed company teammates and applicants. At reputed company, our teammates reputed company bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. reputed company our teammates’ points of view are key to our success, and we reputed company inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, reputed company and welcoming. Apply tot his job Apply To this Job