Senior Manager Information Systems

Lets do this. Lets change the world. The role is responsible for leading and charting the course for the Clinical Data Management and Interactive Response Technologies (CDMIRT) technology product team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for planning, design, configuration, deployment, and support of Veeva Clinical Data Management System (CDMS) and Clinical Database (CDB) systems.

The ideal candidate will have a consistent track record of leadership in technology-driven environments for the Information Systems area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure

• Conducting detailed analysis of clinical trial processes to identify and document functional requirements for Veeva CDMS, including data capture, data validation, reporting, and workflow management.
• Collaborating with technical teams to design system configurations, data mappings, and integrations between Veeva platforms and other clinical systems.
• Ensuring data integrity by defining data quality standards, monitoring data quality issues, and working with data stewards to address discrepancies.
• Supporting the validation processes defined by Amgen for the Veeva CDMS and CBD systems, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout the implementation and ongoing usage.
• Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged
• Lead and manage large, diverse teams within a matrixed organization.
• Collaborate with geographically dispersed teams, including those in the US and other international locations.
• Oversee the software development lifecycle
• Develop and implement strategic plans for technology and workforce.
• Develop a culture of collaboration, innovation, and continuous improvement.
• Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership.
• Responsible for leading, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization
• Understand the decision-making process, workflows, and business and information needs of business partners and collaborators
• Contribute and define business outcomes + requirements, technology solutions, and services
• Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through 'test & learn' activities
• Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met
• Ensure communication of key performance metrics and analysis of unmet needs
• Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery
• Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services
• Ensure alignment of Technology service plans across organization
• Provide education to new partners with regards to IT service offerings
• Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate Degree and 2 years of experience in Business, Engineering, IT or related field OR
• Masters degree with 8 - 10 years of experience in Business, Engineering, IT or related field OR
• Bachelors degree with 10 - 14 years of experience in Business, Engineering, IT or related field OR
• Diploma with 14 - 18 years of experience in Business, Engineering, IT or related field
• Solid understanding of clinical trial processes, including study design, data collection, data management, and regulatory requirements
• Expertise in Veeva CDMS and CDB functionalities, including data entry, data review, reporting, and workflow management
• Experience with business analysis methodologies, including requirements gathering, documentation, and process mapping
• Demonstrated experience in leading technology initiatives and teams with a track record of successful innovation
• Exceptional collaboration, communication and interpersonal skills to effectively manage partner relationships and build new partnerships.
• Experience in applying technology best practice methodologies: Scaled Agile (SAFe), ITIL, etc.

Preferred Qualifications:

• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in the software development lifecycle.
• Experience using and adoption of Scaled Agile Framework (SAFe)
• Strong analytic/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business partners
• Broad working knowledge of key IS domains and layers
• Scaled Agile Framework (SAFe) for Teams required

• Excellent leadership and team management skills.
• Strong transformation and change management experience.
• Exceptional collaboration and communication skills.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented with a focus on achieving team goals.
• Strong presentation and public speaking skills.
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams