Senior Manager, Clinical Trial Transparency
- Posted: over a month ago
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
- Provide leadership, mentorship, and develops personnel by maintaining a positive work environment while overseeing the daily activities of personnel.
- Strong expertise in transparency services including clinical trial disclosures, redaction and anonymization and patient communications.
- Interacts directly and independently with client to coordinate all facets of the project; expert communicator who has developed strong relationships with client.
- Makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.
- Responsible for overseeing and ensuring high-quality transparency deliverables in an efficient manner including document redaction and anonymization.
- Effectively communicates with team/functional leadership, and members of senior management.
- Oversees and leads the initiation, progression, and completion of the exchange of information for all Transparency workflow steps, with high skill and proficiency.
- Strong project management knowledge, including managing complex projects with multiple team members requiring independent coordination with the client.
- Leads and participates in business development activities.
- Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.
- Capable of leading Transparency process/ tool improvement initiatives and may participate in complex companywide process improvement initiatives.
- Knowledge on using anonymization tools with quantitative risk assessment.
- Develops and maintains SOPs, work practices, forms and other documentation, and training materials related to clinical trial disclosures and transparency services.
- Maintains a strong understanding of regulations and guidances as they pertain to transparency; and ensures alignment with company systems and working practices.
- Identifies new industry trends relevant to trial transparency including impacts of changing regulations in this area and impacts to other departments.
- Graduate degree in scientific, medical, clinical discipline or related field, or related experience.
- At least 5 years of experience in a CRO environment.
- Demonstrates managerial skills and prior management experience preferred.
- Sound understanding of clinical development and operations implementation and management, the drug development process, and regulatory guidelines.
- Excellent Scientific Writing Skills.
- Excellent analytical, organizational, and problem-solving skills.
- Proficiency with MS Office Applications.
- Strong communication and presentation skills required.
- Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process.
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