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Lead Clinical Process Specialist, Clin GDN - (1624150) in Mumbai, IN at IQVIA™

Date Posted: 3/11/2018

Job Snapshot

Job Description

Header:Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


Apply clinical research expertise in multiple initiatives by working directly with various stakeholders and ensuring process and practice methodology is applied consistently and in accordance with SOPs, policies, good clinical practices and applicable regulatory requirements. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Mentor/ coach Clinical Process Associate/Specialist colleagues.


• Implementation of specific process initiatives arising out of transformation/innovation/ process re-engineering programs

• Act as clinical research subject matter expert for various initiatives

• Supporting the creation of frameworks, collaterals, whitepapers and accelerators relevant to the areas of expertise.

• Collaborate with respective stakeholders, including operations teams, global teams, and other functional managers as appropriate

• Collaborating with peer business process specialists and promoting cross functional synergies.

• Mentor projects/ initiatives on industry best practices

• Process improvement initiatives – liaise with the Quintiles stakeholders and support teams to review and provide oversight.

• Competency development – Develop training content, deliver training and monitor the growth of the competency

• Process development, process pilots and process transition of key business processes that will be transitioned and executed  by the group

• Develop and deploy competency assessments working with the Global training department

• Work with the delivery team and provide functional support to the teams on an ongoing basis

• Process Quality and audit initiatives - Identify impacted areas, provide root cause and implementation of corrective and preventive action.

• Develop templates, re-usable assets and best practices

• Creation of business cases, proposals and presentations related to the relevant area of expertise

• Review and sign off on project requirements, process flows, gaps, and design documents.

• Perform the User Acceptance Testing; ensure the quality of the deliverable is in line with what has been agreed in the project requirements.

• Work with Enablement group to test the platform perform user testing

• Work with Quality management to develop the QM plan for the work stream


• In depth knowledge of Clinical Research functions like Monitoring, Project Management and Regulatory.

• Strong knowledge of the components of the protocol

• Strong communication and interpersonal skills, including good command of English language

• Excellent problem solving skills

• Good teamwork skills

• Ability to work under limited direction

• Basic software and computer skills, including MS Office applications. Familiarity with related systems and softwares

     utilized in clinical operations.                                                                 

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Job Requirements


• Bachelor's degree in life sciences or related field and min 5 years with  relevant clinical research experience; or equivalent combination of education, training and experience


• Extensive use of keyboard requiring repetitive motion of fingers.

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

• Regular sitting for extended periods of time.

• May require to work in shifts

Connect to great opportunity™

Quintiles is a strong advocate of diversity and inclusion in the workplace.  We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success.  We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.

“Join Us”

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: 1624150