Senior Manager, Clinical Trial Transparency

3 weeks ago


India MMS Holdings Full time

Are you looking to join a company where your contributions truly matter and where you ll be part of a supportive innovative team MMS is a award-winning data-focused clinical research organization CRO We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention rate We support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges With a global footprint across four continents MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive Join us at MMS and be part of a team that is shaping the future of clinical research Discover more about our exciting opportunities and why MMS is a great place to advance your career Visit or follow MMS on Interact with clients and regulatory authorities remotely and onsite including representation at key regulatory meetings on behalf of the client Demonstrated ability to lead manage multiple individuals and or groups Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target Strategically assesses resource utilization and forecasting to ensure companywide goals are met Effectively communicates complex strategic concepts with ability to tailor message to targeted audience Demonstrate thought leadership with customers by developing and presenting client industry trends benchmarking and other pertinent information May participate in industry events for this purpose Demonstrated ability to lead manage multiple individuals and or groups in a global environment Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group and cross functionally to ensure uninterrupted delivery and maintain compliance Ability to facilitate positive group morale and productivity by appropriately including others in decisions plans Manages staff makes decisions and advises others on complex problems understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input Direct manage and oversee the daily activities and workload of the transparency PLS and redaction teams Proactively identifies areas for improvement before issues arise and provides strategic proposal resolution for consideration Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals Job Requirements Graduate degree in scientific medical clinical discipline or related field or related experience Masters preferred Minimum of 6 years experience in clinical trial transparency disclosure or medical writing role At least 5 years of experience in a CRO environment Demonstrated managerial skills and experience preferred High level knowledge of drug development process clinical development and operations with a strong understanding of regulatory guidelines Excellent scientific writing skills Excellent analytical organizational and problem-solving skills Proficiency with MS Office applications Strong communication and presentation skills Knowledge of ISO 9001 ISO 27001 21 CFR Part 11 FDA and GCP requirements Understanding of CROs and scientific clinical data terminology the drug development process



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