Principal Clinical Data Manager (Remote)

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, 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.

Job Specific Skills:

• Lead multiple studies and large DM project teams for different clients.
• Coordination and oversight of vendor data outside of the clinical database.
• Oversight and training on oversight of CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits
• Oversight, training, and perform user acceptance testing (UAT) of EDC and integrated systems including development and training on test plan and scripts.
• Create and train on study tracking and metric reports for use by the study team.
• Ability to train sites/users on EDC applications, UAT, and contribute to development of training materials.
• End user knowledge for study conduct activities including queries management, customized reporting and extracting data in multiple EDC systems.

Core Competencies for Principal Level Role

• Customer Liaison/ Management:
  • Provides subject matter expertise in discussions with the external and internal customers. Leads technical discussions during Kick off Meetings and Business Development activities.
• Level of Independence:
  • Service level project focus. Conducts independent research and provides input and expert knowledge towards the development and execution of set service line or service level objectives. Provides support and guidance to more junior level colleagues.
• Service Management:
  • Contributes to the development of service strategy.
• Impact:
  • Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas; problem-solving frequently requires analysis of unique issues/problems without precedent and/or structure. May manage programs that include formulating strategies and administering policies, processes, and resources; functions with a high degree of autonomy.
• Innovation/ Continuous Improvement:
  • Anticipates internal and/or external business challenges and/or regulatory issues; recommends process, product/service or technology improvements.
• Discretion/ Latitude:
  • Typically operates with broad latitude in a complex environment.
• Problem Solving:
  • Solves unique and complex problems that have a broad impact on the business.
• Communication:
  • Effectively communicates with senior level peer customers. Clearly articulates regulatory requirements and shares expertise and advises on best practices. Presents at the expert webinars and companywide meetings.
• Talent Management/ Supervision/ Mentorship:
  • Leads project teams to achieve milestones and objectives. Provides cross-functional technical mentorship and guidance.
• Quality and Quantity of Work:
  • Produces high quality project deliverables across multiple, high complexity projects with high level of efficiency.

Core Company Values

• Represent self and company in a professional manner and in line with core company values.
• Practice excellent internal and external customer service, communication, and team work.
• Support objectives and improvement efforts within department and organizationally.
• Comply with all applicable policies, procedures, and training requirements.
• Additional tasks as assigned by manager.

Requirements

• Bachelor’s degree in medical, clinical discipline, Masters preferred.
• Minimum of 7 years’ experience in clinical data management or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Understanding of scientific, medical, and/or clinical data required.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 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.

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