MMS Holdings Inc. Associate Director, Clinical Trial Transparency in Charleston, South Carolina
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Roles and Responsibilities:
Provide leadership, mentorship, and develops personnel by maintaining a positive work environment.
Direct, manage, and oversee the daily activities of personnel.
Strong expertise in transparency services including clinical trial disclosures, redaction and anonymization and patient communications.
Responsible for transparency services consulting, strategic advice and operational execution in drug/device/diagnostic developments.
Maintain technical expertise on regulatory requirements and health authority registries for clinical trial disclosures and anonymization assuring alignment with company systems and working practices.
Build and manage cross-functional partnerships with internal colleagues and with external partners.
Interact directly and independently with client to coordinate all facets of the project; expert communicator who has developed strong relationships with client.
Develop and maintain SOPs, work practices, forms and other documentation and training materials related to clinical trial disclosures and transparency services.
Train MMS staff and clients on clinical trial disclosures and anonymization regulations, processes and systems.
Actively promote new business by participating in project bids and client presentations as appropriate.
Strong project management knowledge, including complex projects with multiple team members and independent coordination with the client.
Strong knowledge of the key technical and non-technical roles needed to support Transparency services project end-to-end.
Responsible for project staffing with appropriate resources.
Identify new industry trends relevant to trial transparency including impacts of changing regulations in this area and impacts to other departments.
Promote the growth of TrialAssure applications software/solutions and related services to prospective and existing customers.
Graduate degree in scientific, medical, clinical discipline or related field, or related experience.
At least 5 years of experience in a CRO environment.
Demonstrated managerial skill and experience preferred.
High level knowledge of drug development process
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.
Ability to anticipate and effectively resolve potential problems with client demands.
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 & clinical data/ terminology, & the drug development process.