Senior Clinical Data Manager (Remote - US)
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit 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/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs.
- Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships.
- Responsible for 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 ability to capture protocol information in database successfully.
- Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management.
- Creates training exercises; serves as 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 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.
- Preparation of any study tracking and metric reports for use by the study team.
- Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.
- Interacts with cross-functional team members to ensure completion of all timelines and studies.
- Participates in data management and/or organizational initiatives.
- Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements.
- May act as resource for QC activities in collaboration with QC Coordinator.
- Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).
- Confident, positive attitude displayed towards clients and projects.
- Willingness to learn new skills and expand knowledge of drug development.
- Leads data management projects with little management oversight.
- Ability to work independently and resolve issues.
- Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.
- Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.
- 5+ years’ experience in data management field with a minimum of 1 year of experience 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, as well as, interpersonal and organizational skills.
Recommended Jobs
Field Service Engineer II - Travel
Job Description Job Description Job Title : Field Service Engineer - Travel Reports to: Regional Field Service Supervisor – North America Classification: Non-Exempt Summary: This p…
Parent Child Gymnastics Class Instructor
Job Description Job Description Benefits: Opportunity for advancement Free uniforms Training & development Life’s too short to not work someplace awesome! If you love kids, enjoy movi…
Janitor
Job Description Job Description MISSION : Our mission, grounded in traditional Native American culture, is to reduce health disparities by delivering high-quality, comprehensive integrated he…
Local CDL-A Dedicated Driver -- Home Daily | Phoenix Region
Job Description Job Description Class A Local Route Driver – Home Every Night If you live in the Phoenix area and want to stop sleeping in a truck, we have a local driving slot open right now. T…
Accounting Assistant
Job Description Job Description JOB SUMMARY: Position performs accounting transactions in an accurate and timely manner. Conducts all duties associated with a bookkeeper position. ESSENTIAL…
Activities Event Staff - Seasonal
Job Description Job Description Description: Season: Beginning on or about 10/01/2026 through on or about 04/15/2027 About Roberts Resorts & Communities: This company operates nationall…
Account Manager- Entry Level Sales
Job Description Job Description Benefits: Bonus based on performance Employee discounts Training & development Benefits/Perks Competitive Compensation Employee Discount Caree…
Leasing Agent
Job Description Job Description Leasing Agent Company: Greenwater Investments Location: 6430 N Swan Rd, 85718 Tucson, AZ Employment Type: Full-Time Position Summary Greenwater I…
Structural Welder 2nd Shift
Job Description Job Description Job Title: Structural Welder $24.35/Hr – 2nd Shift Job Description We are seeking a skilled Structural Steel Welder to join a busy 2nd shift operation, weldi…
Assistant Operating Director - Central Phoenix
Job Title: Assistant Operating Director Reporting To: Operating Director Status: Exempt Employee and Fringe Benefits: ● Medical Insurance ● Dental Insurance ● Vision Insurance ● P…