Clinical Research Manager

2 weeks ago

Baltimore, United States Amberimplants Full time

Amber Implants, a forward-thinking medical device start-up in the field of orthopedics and spine, is looking for an experienced individual to join our team as a Clinical Research Manager. This vital role will be focussed on all activities related to our clinical trials including the development, implementation, and execution of clinical research strategies for a class III orthopedic implant. Responsibilities

Develop and implement comprehensive clinical research strategies in alignment with company goals and regulatory requirements. Oversee the planning, initiation, and execution of clinical trials according to the clinical research strategies, ensuring adherence to study protocols and timelines. Collaborate with medical professionals and internal teams to design and develop study protocols for spine-related clinical trials, considering the unique challenges and opportunities in the spine sector. Collaborate with cross-functional teams to define project objectives, milestones, and deliverables. Manage relationships with clinical research organizations (CROs), investigators, and study sites to facilitate successful trial execution. Ensure compliance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and relevant regulatory standards. Prepare and submit regulatory documents for the FDA or European authorities Collaborate with the Medical Affairs team to provide medical and scientific expertise for clinical trial design and implementation. Supervise and mentor clinical research staff, guiding study conduct, monitoring, and data management. Control and oversee data collection and management processes, collaborating with data management teams to ensure the accuracy and integrity of spine trial data. Evaluate and select external vendors, negotiate contracts, and manage budgets for clinical trial activities. Maintain up-to-date knowledge of industry trends, regulatory developments, and advancements in clinical research methodologies. Effective communication and collaboration with internal stakeholders, including regulatory affairs, quality assurance, andmarketingteams. Collaborate with R&D, engineering, andmarketingteams to integrate clinical insights into product development, ensuring that spine devices meet both clinical and market needs. You have

MD, MSc, or PhD degree in biomedical science, biomechanics, medicine, or other relevant scientific disciplines. Expert knowledge of spine and orthopedic field, pathology, and surgical procedures. Proven experience (minimum 5 years) in clinical research management within the medical device industry, preferably with a focus on orthopedic spine devices.

Extensive experience in designing and conducting clinical trials. Experience in preparing regulatory submissions for orthopedic spine devices and familiarity with the cultural and regulatory differences across European countries. Knowledge of regulatory requirements for clinical trials in Europe, including familiarity with the European Medicines Agency (EMA) guidelines. Experience in managing multi-site and multinational clinical trials. Ability to collaborate with various stakeholders, including investigators, site coordinators, and regulatory agencies. Strong project management skills with the ability to lead and coordinate multifunctional teams. Knowledge of Good Clinical Practice (GCP) and other relevant guidelines and a strong commitment to ethical standards in clinical research. Familiarity with electronic data capture (EDC) systems and clinical trial management software. Effective communication skills to ensure a clear understanding of trial objectives and requirements. Excellent communication and interpersonal skills. Ability to manage multiple priorities and deadlines in a dynamic start-up environment. Well-established professional network within the clinical research community. About the company

Amber Implants is a fast-growingclinical-stage medical device start-up operating in the orthopedics and trauma field. We have created a novel spinal implant (VCFix Spinal System) for treating traumatic vertebral fractures in a minimally invasive approach. We have completed all preclinical testing of this product and started in-human clinical trials.Amber Implants has a flat organizational structure composed of a young, ambitious, and rapidly expanding team, located in WTC, the Hague, with a modern atmosphere and an informal culture. We are a company that recognizes your efforts, listens to your suggestions, gives you feedback to improve, and congratulates you on your achievements, making it a pleasant work environment. The vacancy is for a full-time position (36-40 hours per week). We are flexible in our work times, but it is preferred to be at the office when working. To apply, please send you motivation letter together with you full CV and motivation letter to info@amberimplants.com For more information you can alwayscontact us.

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