ProClinical is seeking someone to fill the contract position of a Senior Clinical Study Manager, operating in Princeton, NJ. The position will include conducting clinical studies to support regulatory submissions and posting market surveillance of client products. Conduct observational studies. Additionally, the correct applicant will ensure adherence to Good Clinical Practices and applicable regulations, standard operating procedures, client’s Code of Conduct, and study protocols in accordance with established budgets and timelines.
- Independently assess study feasibility, work with Clinical Strategy Lead through the study design process, and collaborate with project team to develop clinical study protocols and associated documents.
- Independently train investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on study related procedures. Provide first tier support for protocol, SOPs, and systems.
- Independently plan, manage, and report all aspects of global clinical studies through oversight of cross-functional study activities.
- Independently create and report clinical study updates to management on a regular basis; report on performance to plan.
- Coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510(k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions as directed.
- Independently liaise with ASD product teams and in country sales and marketing personnel to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the clinical study.
- Independently monitor and/or oversee monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements, and client procedures.
- Follow current SOPs. Conduct peer training on processes/procedures. Evaluate current procedures for efficiencies and quality as well as make recommendations to management for improvements; may assist in leading process improvement initiatives. Create/implement SOPs as directed.
- Independently organize and lead internal and external meetings with associated communications and materials.
- Independently contribute to scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate.
- Travel domestically and internationally up to 25%.
Skills And Qualifications:
- Bachelor's degree in life sciences or related field or equivalent education and experience.
- Minimum 8-10 years' experience in medical device industry, clinical setting, or research field.
- Study Management/Project Management skills.
- Demonstrates understanding and quality delivery of study milestones according to established timelines.
- Ability to handle complex projects/problems.
- Ability to identify investigational sites and investigators.
- Strong negotiation and professional communication skills.
- Strong written and oral English skills.
- Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, ISO, ICH, etc.).
- Product and indication/disease knowledge, with an understanding basics of surgical procedures.
- Contribute to design teams and clinical development plans for lifecycle of product.
- Desire and ability to mentor/coach study management staff.
- Ability to work independently, apply in-depth knowledge, and lead and direct others.
- Experience with Microsoft Excel, Word, PowerPoint, Outlook, SharePoint, Project and Visio.
- Proficient with clinical trial management systems, trial master file systems, and electronic data capture.
- CCRP or CCRA certification preferred.
- Valid driver’s license.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Estella Nchumulah at (+1) 267 943 3657 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.