Director, Data Services

Client Services Remote, United States

Position at Medidata Solutions

Medidata: Conquering Diseases Together

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at

Acorn AI is one of the largest AI companies exclusively dedicated to life sciences. It’s built on Medidata’s platform that includes the industry’s largest structured, standardized and growing clinical trial data repository consisting of 17,000+ trials and 4.5M patients. Our team is composed of over 40 PhD/Masters statisticians, data scientists, analytical product leads, former FDA biostatisticians and computational genomicists. 

Your Mission: 

  • The Director of Data Services will manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.

  • This includes all aspects of people management and development for Data Services for both onshore and offshore resources.

  • Work with peers in Technical Services to identify, set, measure and control how we connect and serve data to drive trial health including providing consultation on Solution Design and Reporting Standards.

  • Work with peers on the Patient Cloud Leadership team to develop key initiatives that further enhance sense of purpose and inclusion for all Patient Cloud Staff.

  • Provide comprehensive data management expertise to the Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.

  • Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. 

  • May perform the role of the Data Services Lead or Associate on any given project as the function develops to share capability as SME to groom other team members and balance out the work in early functional development.

  • Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents

  • Participate in and support RFP process (review RFP documents, pricing, attend bid defense) 

  • Identify new Service opportunities and implement them to create growth.

  • Lead and/or participate in a focus team or global or local best practice team.

  • Communicate lessons learned and/or present in CDM workshop(s) 

  • Plan, develop and implement new technology or tool

  • Present at professional conferences and/or publish articles in professional journals 

  • Provide review and input on developing, revising, and maintaining core operating procedures and work instructions 

  • Perform other duties as directed by the functional manager 

Your Competencies: 

  • Experience Serving as escalation point of contact for customer on data management deliverables

  • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise

  • Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources 

  • Maintain strong customer relationships

  • Ensure open communications with customer and Medidata management to manage and meet contractual obligations Service Management

  • Meet with Project Management and Implementation team members on a regular basis to ensure milestones meet timelines and quality deliverables

  • Establish strong communications with Data Services team, project managers and all other stakeholders 

  • Support DM service delivery with comprehensive DM process and technical expertise in executing projects

  • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution

  • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables

  • Create and/or review and sign-off on all data management plan (DMP) documents

  • Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW

  • Implement proactive quality management plans across multiple projects/programs. Track service performance and provide leadership to identify root causes of issues and implement remedial actions

  • Continuously look for opportunities to improve service; work with team to develop and implement plan to reorganize and drive change across multiple projects/programs (with minimal support)

  • Ensure timely follow-up and resolution of compliance issues

  • Serve as Subject Matter Expert (SME) 

  • Provide leadership and expertise in a specific CDM task or technology 

  • Train and mentor junior Data Services staff in DM expertise - onshore and offshore. May coordinate the work of more junior DTL staff

  • Maintain internal tracking databases and systems Financial Management/Business Development Support:

    • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)

    • Manage SOW/budget

    • Review financial reports on a monthly basis and participate in project reviews as requested

    • Identify out of scope tasks and track change orders to completion

    • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing 

  • Independently bring solutions to the CDM team/CDM department

  • Lead and/or participate in a focus team or global or local standard methodology team

  • Communicate lessons learned and/or present in CDM workshop(s) 

  • Participate in the development and implementation of new technology or tool 

  • Present at professional conferences and/or publish articles in professional journals

  • Perform other duties as directed by the functional manager

  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology

  • Knowledge of operating procedures and work instructions and the ability to apply them in practice

  • Knowledge of GCP and relevant regulatory guidelines

  • Excellent communication, interpersonal, customer service, and teamwork skills

  • Excellent project management skills

  • Excellent organizational and analytical skills

  • Comprehensive understanding of clinical drug development process 

  • Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology) 

Your Education & Experience:

  • Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 8 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

  • Extensive experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programs)

  • Previous experience of handling customer negotiations

  • Occasional travel is required

Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform. 

Medidata Solutions have powered over 20,000+ clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.

Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.