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Sr. Clinical Operations Associate / Clinical Operations Manager (to be decided based on experience) Job Type: Full-time Number of openings for this role:1 Full Job Description Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and musculoskeletal disorders. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. We are searching for an experienced and driven Sr. Clinical Operations Associate / Clinical Operations Manager (to be decided based on the level of experience) with a background in biotech/pharmaceuticals/CRO. This position is a full-time salary role. Position Description Reporting to the Vice President, Global Clinical Development & Operations, this role manages one or more clinical studies from Protocol Concept to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with a proven track record of managing studies, including internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures Essential Duties & Responsibilities: Managing study progress from start-up to close-out activities and end of study reporting. Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans. Coordinating interdisciplinary activities throughout the study. Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality. Oversight and management of multiple clinical trials from early development through licensure. Lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management. Proactively managing study deliverables and milestones, including identifying and resolving trial related issues (quality, timelines, budget, resources). Writing clinical related deliverables (e.g., Investigator Brochure, clinical protocol/amendments, Annual Reports/DSUR, eCTD clinical modules, response to FDA questions, etc.) Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is required) Participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), and collaboration with Clinical Quality and Laboratory staff on study compliance initiatives. Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, timelines, monitoring plans, laboratory manuals, training materials, and site initiation visit slide presentation. Effective communication with KOLs and Investigator site staff to support study del very. Contributing to individual and team development through training initiatives and team building activities. Qualifications: Bachelor s degree in biological science, nursing, pharmacy or equivalent as a minimum. Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions. Proven track record including internal cross-functional coordination, CRO and vendor management to deliver high quality studies to time and budget. Previous pharma industry experience Managing early through late studies with preference to early phases. Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges. Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate rapidly changing priorities and deadlines. Solid project and vendor management, analytical and problem-solving skills. Prior experience with forecasting, tracking and reconciliation of study budgets. Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports. Excellent written and verbal communication skills. Schedule: Monday to Friday Work Location: Remote Travel to clinical site locations within the United States (up to 25% travel) Travel onsite to Rochester, Minnesota typically once a month Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. We provide a competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion: Full Health, Dental and Vision Insurance for employees and their dependents. Health Insurance including PPO or High Deductible Health Plan with Health Savings Account. Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Life Insurance basic life and supplemental life insurance options for self, spouse, children Short and Long-Term Disability Insurance Paid Time Off Paid Holidays Parking benefits Rion is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.