Senior Manager, Clinical Trial Transparency & Disclosure (Remote)
Senior Manager, Clinical Trial Transparency & Disclosure (Remote)
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Job Description
Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS is a awardwinning datafocused 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 industryleading 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 follow MMS on LinkedIn.
Responsibilities:
- 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.
- Crossfunctionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain ontrack 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 interdepartmental 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.
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 problemsolving skills.
- Proficiency with MS Office applications.
- Strong communication and presentation skills.
- Knowledge of ISO 9001 ISOCFR Part 11 FDA and GCP requirements
- Understanding of CROs and scientific & clinical data/ terminology & the drug development process.
Required Experience:
Senior Manager
Employment Type
Full-Time
