Medidata: Powering Smarter Treatments and Healthier People
Medidata, a Dassault Systèmes company, is leading the digital transformation of life sciences, creating hope for millions of people. 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 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Known for its ground-breaking technological innovations, Medidata has supported more than 30,000 clinical trials and 9 million study participants. And Medidata’s ongoing commitment to infusing the patient voice into trial designs and solutions is helping to create a better and more inclusive experience for all participants in clinical studies. Medidata is involved in nearly 40% of company-initiated trial starts globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.
The Director Strategy & Transformation (S&T), Clinical Data Management (CDM), is a Management Consultant responsible for driving the vision and focus of Medidata’s S&T Team. Creating consulting and services offerings through value engagement models that support our customers efforts on platform implementations, digital transformations and analytically driven operating models. Proactively identify and cultivate business opportunities that support the adoption and optimization of the Medidata Clinical Cloud.
· Engage with senior level clients to collaborate through value engagement models and solution approaches to improve and grow their ability to meet business objectives.
· Serve as a trusted advisor to clients and form "trusted mentor" relationships to influence at all levels of client organizations, including C-Suite personnel.
· Solid expertise in Data Management strategy with the ability to assess an organization's existing data management capabilities and technologies used to support their data lifecycle.
· Drive consulting excellence by identifying and implementing industry best practice, best-in-class consulting methodologies within Life Sciences companies.
· Facilitate turning ideas and initiatives into tangible results for both internal and external customers.
· Effectively operate and be comfortable working with undefined criteria (gray space) to create defined deliverables.
· Drive adoption and use of creative problem-solving practices, that focus on human centered solutions and outcomes.
· Identify consulting offerings that support digital transformations and analytically driven operating models.
· Ensure the strategic recommendations and creative deliverables surpass client expectations.
· Maintain referenceable clients from beginning to end of the project life cycle.
· Provides clinical data management leadership within the S&T team to align on and drive data collection requirements for one or more complex clinical data management projects.
· Lead innovation and process improvement initiatives and participate in cross-functional initiatives.
Clinical Data Management
· Responsible for end-to-end clinical data management expertise and serves as a primary point of contact for internal team and external, customer facing teams.
· Provides strong quality and project oversight for data management deliverables.
· Provides data standard conventions and quality expectations for clinical data management projects.
· Represents DM on cross-functional project teams (internally and client facing).
· Manage direct reports – if applicable (i.e., hires, trains, appraises rewards, motivates, disciplines, creates Performance Improvement Plans, recommends termination as necessary, etc.).
· Collaborate as an active team member with other products and services departments, as well as Sales, Customer Success, People Team and Product Development as necessary.
· Responsible for coaching and mentoring team members, which may include indirect supervision of employee as well as supervising the work of contract resources.
· Participates in direct customer and sales support.
· Work in collaboration with Sales and Marketing teams to create demand and preference for our consulting services.
Experience and Expertise Required
· Bachelor's degree required with an advanced degree preferred.
· Minimum 12-15 years of relevant industry (Biopharmaceutical) experience.
· CCDM certification required.
· Ensures project adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Medidata Standard Operating Procedures (SOPs), and to functional quality standards.
· Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with internal and client teams.
· Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.
· Strong knowledge and experience of EDC systems (Medidata RAVE, Veeva Vault EDC preferred).
· Demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
· Expertise in DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
· Strong project management skills.
· Exhibits expertise in metrics analysis and reporting methodologies.
· Excellent oral and written communication skills.
· Communicate effectively with senior management and cross-functional teams
· Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].
· Proven consulting and engagement management skills and prior consulting experience a must.
· Excellent written and verbal communication skills.
· Willingness to travel up to 25%.
Nice to have:
· Master's degree in related field
· PMP Certification or Lean Six Sigma Green Belt
As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location.
The salary range for positions that will be physically based in the NYC Metro Area is $160,000-210,000.
The salary range for positions that will be physically based in the California Bay Area is $165,000-222,000.
The salary range for positions that will be physically based in the Boston Metro Area is $155,000-207,000.
The salary range for positions that will be physically based in Texas or Ohio is $140,000-185,000.
The salary range for positions that will be physically based in all other locations within the United States is $140,000-188,000.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata’s non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off; and 10 paid holidays per year.
MEDIDATA generates the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes.