Medidata Solutions

Support planning and conduct of clinical studies, provide data management guidance, and ensure data quality in clinical trials. | Minimum 5 years in clinical data management, 3+ years in eCOA, and experience with clinical trial software and project leadership. | Location: Hybrid Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week in accordance with Company policy. About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at www.medidata.com . About the Team: The Data Services Senior Implementation Consultant help ensure that Medidata’s software applications are implemented or enabled in accordance with Medidata standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. SICs also consult with our clients, provide guidance and make suggestions on how to best implement Medidata’s software to provide the most value. The SICs work with Project Managers and other functional departments during the implementation or enablement of Medidata’s software applications, in addition to helping in the training, education and mentoring of colleagues. SICs are leaders of clients and internal colleagues, as well as champions of our products and processes. Responsibilities: • Support planning and conduct of eCOA clinical studies across the phases (I-IV) • Provide solid Data Management expertise and guidance during decision making and/or issue resolution process • Contribute to cross-functional expectations on data quality and data cleaning activities incorporated into the Data Management Quality Plan • Provide ongoing data cleaning to identify issues/risks in data quality and data cleaning performance • Support and maintain strong alliances with other functions and with CRO partners • Discuss and design project specific technical solutions which support the data management plan • Continuously improve Data Management service processes and data quality measures • Deliver high quality Clean Databases • Is a member of the client team and internal study team and lead relevant discussions • Contributes to a transparent benchmarking of Data Management activities within function and study team • Initiates the DTS package and contributes to the set-up and testing of the eCRF incl. Edit Checks, data listings, and reports, in close cooperation with study team • Serves as main contact on implementation topics related to data management activities. (e.g. mentoring junior staff, training team members, leading or contributing to expert working groups) Qualifications: • Deep experience in clinical development, especially demonstrating expert knowledge of strategy, operations, and analytics within the Clinical R&D space • Expertise in study planning and optimization, and knowledge across eCOA clinical development practice areas/technologies as a whole • Demonstrated ability to drive, delegate, and deliver multiple, (manage) complex projects and projects to success • Strong, clear communicator with ability to consult confidently; has good command of public speaking and presentation skills • Minimum 4-year university/college degree or equivalent (analytic discipline a plus) experience with a minimum of 5years of experience • 3+ years related eCOA experience • 5+ years in Clinical Data Management • Multi-year experience working with clinical trials, or equivalent combination of education and experience required. • Prior data management or clinical trial software consulting experience preferred. • Demonstrated experience leading and supporting project teams and meeting project timelines 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 $96,000.00 – 128,000.00 • The salary range for positions that will be physically based in the California Bay Area is $101,250.00 – 135,000.00 • The salary range for positions that will be physically based in the Boston Metro Area is $94,500.00 – 126,000.00 • The salary range for positions that will be physically based in Texas or Ohio is $84,375.00 – 112,750.00 • The salary range for positions that will be physically based in all other locations within the United States is $85,000.00 to 114,000.00 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; flexible paid time off; and 10 paid holidays per year. Note: Please be on the lookout for job scams. Medidata recruiters will never ask applicants for monetary compensation, credit card, or banking details. Equal Employment Opportunity : In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applications will be accepted on an ongoing basis until the position is filled. Inclusion Statement As a game-changer in sustainable technology and innovation, Medidata, a Dassault Systèmes company, is striving to build more inclusive teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.

Oversee and develop project management teams, ensure project delivery on time and within budget, and foster client relationships. | Minimum 8 years in clinical research or related technology roles, 5 years of line management experience, strong communication skills, and a relevant degree. | Location: Hybrid Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week in accordance with Company policy. About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at www.medidata.com . About the Team: The Director, Project Management is responsible for overseeing Project Management teams through the successful implementation of studies on time and within budget across all Patient Cloud services through effective management of Medidata resources. Contributes to driving Partner, Sponsor, Site, and Patient success. Responsibilities: • Apply people leadership in all of the following areas: • Management of Project Management resources responsible for Patient Cloud projects in US and EMEA regions • Leadership and development of direct reports including activities such as hiring, performance management, coaching, mentoring, disciplinary actions, etc. • Manage work assignments and utilization for direct reports, leveling work across resources as needed • Identify individual strengths and assign tasks, while in parallel identifying growth and development areas • Interdepartmental collaboration with Market Segment Senior leaders in US, EMEA, APAC and APeJ • Foster collaborative and mutually supportive relationships bi-directionally, assess cross-functional project team capability and provide training and support to enhance aptitude and improve development and project results • Monitor interdependencies and coordination across projects to ensure that information relating to project deliverables, risks and issues are effectively communicated and that key performance indicators are monitored and evaluated • Assist in the creation of functional strategies and specific objectives to achieve departmental goals • Identify process improvements and drive strategy • Maintain client relationships by providing guidance and consulting to clients around the best use of the Medidata Applications in addition to proactive communication and issue management • Support pre-sales activities in addition to those that will result in the expanded use of the Medidata Applications and Services • Assure compliance with Medidata's standard project management methodologies and SOPs • Provide support for timely completion of quality incidents including corrective and preventive actions Qualifications: • Possess a solid understanding of clinical research, including eCOA, eConsent and/or Virtual Trials • Ability to anticipate and mitigate complex issues and risks thus minimizing escalations • Ability to identify and suggest improvements which increase the value proposition for Medidata and the client • Ability to mentor other team members and serve as a team leader • Proven skills in training & education and best practices • Demonstrate strong verbal/written communication and organizational skills • Excellent computer skills, public speaking, presentation and teaching skills • Self-motivated and able to assume responsibility in a professional manner • Demonstrated track record of working independently in an advisory capacity • Experience in leading project initiatives and meeting project timelines • 10% - 20% travel required • Bachelor's degree required; Master's degree preferred (analytic discipline desired) • Minimum of 8 years relevant experience with clinical research organizations using technology to drive Patient Experience • Minimum of 5 years line management experience in project assurance discipline • Project Management experience required, PMP certification preferred 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 $157,500 to $210,000.00 The salary range for positions that will be physically based in the California Bay Area is $166,500.00 to $222,000.00 The salary range for positions that will be physically based in the Boston Metro Area is $155,250.00 to 207,000.00 The salary range for positions that will be physically based in Texas or Ohio is $138,750.00 to 185,000.00 The salary range for positions that will be physically based in all other locations within the United States is $141,000.00 to 188,000.00 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; flexible paid time off; and 10 paid holidays per year. Note: Please be on the lookout for job scams. Medidata recruiters will never ask applicants for monetary compensation, credit card, or banking details. Equal Employment Opportunity : In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applications will be accepted on an ongoing basis until the position is filled. Inclusion Statement As a game-changer in sustainable technology and innovation, Medidata, a Dassault Systèmes company, is striving to build more inclusive teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.