MMS
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Senior Clinical Data Manager
role at
MMS . MMS is an award-winning, data-focused clinical research organization (CRO). We are a Great Place to Work certified organization, recognized for our culture and employee retention. We support the pharmaceutical, biotechnology, and medical device industries with our scientific approach to complex trial data and regulatory submissions. With a global footprint across four continents, MMS maintains a strong customer satisfaction rating and fosters a collaborative, inclusive work environment where employees can thrive. Join us at MMS and be part of a team shaping the future of clinical research. Discover exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Roles and Responsibilities Confidently displays excellent internal and external customer service. Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution. Interacts directly and independently with DM suppliers including EDC and IWR; expert communicator, negotiating with suppliers to meet business needs where necessary. Interacts directly and independently with clients to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships. Responsible for the entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management. Actively participates in protocol review with clients, providing suggestions regarding how to capture protocol information in the database successfully. Strong understanding of GCP/ICH guidelines and FDA regulations as applicable to data management. Creates training exercises; serves as a mentor and trains new clinical data managers. Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with the clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits. Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan. Prepares study tracking and metric reports for the study team. Oversees execution of user acceptance testing (UAT) of study-specific systems and applications. Interacts with cross-functional team members to ensure timely completion of all timelines and studies. Participates in data management and/or organizational initiatives. Initiates SOP updates and provides specifications for DM systems/tools and process enhancements. May act as a resource for QC activities in collaboration with the QC Coordinator. Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures). Maintains a confident, positive attitude toward clients and projects. Willingness to learn new skills and expand knowledge of drug development. Leads data management projects with minimal supervision. Ability to work independently and resolve issues; ability to clearly articulate DM services and trade-offs of various DM approaches for a client or operating model, including potential attendance at web or remote capabilities and bid defense meetings.
Requirements
Bachelors or Masters Degree in a scientific or health care field preferred with relevant experience. 5+ years experience in data management with a minimum of 1 year leading projects. Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems. Extensive knowledge of Clinical Operations SOPs and Working Practices. Excellent verbal and written communication skills, along with interpersonal and organizational skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at MMS. #J-18808-Ljbffr
Senior Clinical Data Manager
role at
MMS . MMS is an award-winning, data-focused clinical research organization (CRO). We are a Great Place to Work certified organization, recognized for our culture and employee retention. We support the pharmaceutical, biotechnology, and medical device industries with our scientific approach to complex trial data and regulatory submissions. With a global footprint across four continents, MMS maintains a strong customer satisfaction rating and fosters a collaborative, inclusive work environment where employees can thrive. Join us at MMS and be part of a team shaping the future of clinical research. Discover exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Roles and Responsibilities Confidently displays excellent internal and external customer service. Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution. Interacts directly and independently with DM suppliers including EDC and IWR; expert communicator, negotiating with suppliers to meet business needs where necessary. Interacts directly and independently with clients to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships. Responsible for the entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management. Actively participates in protocol review with clients, providing suggestions regarding how to capture protocol information in the database successfully. Strong understanding of GCP/ICH guidelines and FDA regulations as applicable to data management. Creates training exercises; serves as a mentor and trains new clinical data managers. Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with the clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits. Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan. Prepares study tracking and metric reports for the study team. Oversees execution of user acceptance testing (UAT) of study-specific systems and applications. Interacts with cross-functional team members to ensure timely completion of all timelines and studies. Participates in data management and/or organizational initiatives. Initiates SOP updates and provides specifications for DM systems/tools and process enhancements. May act as a resource for QC activities in collaboration with the QC Coordinator. Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures). Maintains a confident, positive attitude toward clients and projects. Willingness to learn new skills and expand knowledge of drug development. Leads data management projects with minimal supervision. Ability to work independently and resolve issues; ability to clearly articulate DM services and trade-offs of various DM approaches for a client or operating model, including potential attendance at web or remote capabilities and bid defense meetings.
Requirements
Bachelors or Masters Degree in a scientific or health care field preferred with relevant experience. 5+ years experience in data management with a minimum of 1 year leading projects. Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems. Extensive knowledge of Clinical Operations SOPs and Working Practices. Excellent verbal and written communication skills, along with interpersonal and organizational skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at MMS. #J-18808-Ljbffr