Operational Advisor (RBQM)

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Your Mission:

The Professional Services Operational Advisor [Risk Based Quality Management (RBQM)] is a Subject Matter Expert (SME) role focusing on advising and mentoring our clients/partners during and after implementation of Medidata Clinical Cloud Products on our Unified Platform. Using your operational experience in Clinical Operations and risk management during the lifecycle of a clinical trial, you will be a key member of the Medidata Professional Services team, driving the successful implementation and adoption of one or more Medidata Clinical Cloud Products within our Partners. 

Key activities performed by the Professional Services Operational Advisor (RBQM) will include:

• Provide strategic input, guidance, advice, knowledge and best practices to support client/partners in driving implementation and adoption of Medidata Clinical Cloud Products

• Advise and mentor clients/partners during implementation which includes workshop delivery 

• Establish “Trusted Advisor” Partner relationship through effective consultation 

• Provide operational expertise during and after Implementation and Enablement activities

• Develop and maintain relationships with internal Subject Matter Experts

• Attend Key Operational Meetings in support of Medidata Clinical Cloud Products

• Work closely with the relevant Sales team members to support further adoption of product across the platform

• Where appropriate, develop operational specific materials to support the use of Medidata Clinical Cloud Products

• Work with external and internal business partners to facilitate streamlined site payments on behalf of our clients/partners

• Provide reporting support to clients and enable them to analyze and gain insights into their clinical and operational data

• Deliver new release technical overviews, knowledge transfer and risk assessments to support implementation of new releases (where applicable)

The Professional Services Operational Advisor (RBQM) is responsible for maintaining a high-level of expertise for RBQM Products. They are expected to invest approximately 15% of their time in the following key internal Medidata activities:

• Maintain individual Product and Industry expertise by attending regular Product Training and external industry training, e.g. conferences.

• Represent Professional Services team in Product Adoption and Optimization (PAO) workstreams and initiatives; sharing knowledge back to the full Professional Services team

• Along with other Operational Advisors, lead the maintenance and development of the Accreditation program for the relevant Medidata Clinical Cloud Products ensuring it is kept up to date and relevant with new release information

• Support training of wider Professional Services team to enhance Product and Industry knowledge across team

• Submit defect and enhancements on behalf of clients that require addressing by Medidata Product teams

• Provide operational insight to defect and enhancement requests 

• Provide operational input to Medidata’s implementation process, best practices and collateral roadmaps ensuring that Professional Services team is represented

• Attend specific Product Forums related to Medidata Clinical Cloud Products

• Ensure Medidata’s Quality System Documents (QSDs) and other process documents are up to date as products and processes evolve

• Collaborate with Medidata Global Education Team on the development of training plans and collateral material.

The Professional Services Operational Advisor (RBQM) will collaborate with the following teams:

• Technology team 

• Product Adoption and Optimization (PAO) 

• Medidata Global Education Team 

• Professional Services teams

• Operational Excellence 

• Sales

• Customer Support

• Customer Success

Your Competencies: 

The successful candidate will have:

• Ability to challenge processes that are inefficient or counterproductive and establish/deploy new processes to improve efficiency, strong change management and collaboration skills. 

• Demonstrated practical knowledge of Clinical trial software technology

• Excellent interpersonal, organizational, communication (public speaking and teaching), presentation and writing skills

• Proven ability to successfully work independently on new projects and initiatives while also being able to collaborate with others when needed to achieve goals

• Ability to overcome obstacles, troubleshoot and reach resolutions 

• Willingness for up to 30% national/international travel time

In addition, the candidate will:

• Be self-motivated

• Demonstrate they can work independently

• Seen to take initiative and demonstrate responsibility and accountability

• Collaborate well with other functions/departments

Your Education & Experience:

• Typically requires 8+ years experience from Clinical Operations roles in Sponsor, CRO or other equivalent organizations 

• Clinical trial risk identification and management experience required

• Degree required or equivalent experience

• Medidata employees: At a minimum Senior Implementation Consultant or Senior Project Manager level (or above)

• Leading change & strategic thinking

• Creating/leading strategic initiatives

• Leading teams - both internal and customer - during the implementation of a 'change management (or other)' initiative

• Consulting/advising customers

• Senior/Exec level engagement with customers - and internal stakeholders

• Involvement in the selling process - and making presentations to customers 

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’s solutions have powered over 14,000 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.

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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.