For our Swiss customer located in Basel we are currently looking for (m/f) a Business Application Manager
The Business Applications Manager (BAM) is in the Product Development Global Operations (PDG). Systems and Process and Excellence (SPE) function, and a member of the Business Applications and Support (BAS) team. The BAM is responsible for serving as a key operational business system contact for one or more assigned clinical system(s). The BAM collaborates with cross-functional teams including Informatics, Training & Support Services (TSS), internal/external business stakeholders, and system vendors to ensure clinical systems effectively support the business processes and align with company and regulatory requirements in support of data quality and overall PDG System Excellence strategies. Under the supervision of the Business Application Leader, the BAM provides input into the clinical system roadmap.
Main Responsibilities and Accountabilities
- May serve as a Business Lead/Business Owner for PDG systems, with support form Business Application Leader
- Builds and maintains functional knowledge for assigned systems & associated business processes
- Establishes relationships with business stakeholders (internal and external) to understand the strategic direction and priorities for the organization and supports the plan for alignment of the system capabilities
- Partners with Informatics to: Prioritize and manage the activities of the system operational support team, with support from Business
- Application leader, as necessary: Ensure that systems meet business requirements, systems goals, and fulfill end-user requirements, Provide input into the annual budget to incorporate adequate resources required for maintenance activities
- Partners with Business Process Owner, Key Business Stakeholders, Training Leads, and Support Leads to: Help ensure PDG systems align with process, and that training, and user support are fit for purpose, Help ensure alignment of internal and external (CRO) systems and processes, Help create visibility to management, tracking & resolution of system issues and defects, Maintain and publish system-specific supporting documentation and information, Support cross-domain technology and process improvement initiatives
- Supports the Business Applications Leaders (BALs) to: Review and analyze existing systems effectiveness and efficiency, and develop strategies for improving or leveraging systems, Prioritize Business Applications & Support work, evaluate system landscape, determine system strategies, and coordinate roadmap and budgeting processes
- Plans, manages & facilitates delivery of system related communications to key stakeholders, including: Participate in community and capability building efforts, to cultivate and disseminate knowledge of best practices,Collaboration with study teams, internal and external users to ensure understanding and awareness of processes and procedures surrounding the setup and use of assigned systems, Prepare periodic status reports for stakeholders and management
- Supports the management of system change requests in partnership with Informatics to: Evaluate and prioritize change requests considering system roadmap, business impact and risk, Coordinate assessment of impact on business process, training, reporting, & system landscape, Supports the determination of business priorities and recommend business on options, risks and costs versus benefits of various solutions, Help ensure maintenance and transparency of information on the assessment, approval/rejection, and implementation status of change management activities
- May assume the UAT Business Lead role for system releases and enhancements, including:Participate in validating, testing, and coordinating updating of related system documentation, Ensure relevant test scenarios are provided for the testing team, Review test plans to ensure traceability to end user requirements, Review testing results to ensure they correspond to the business expectations
- Bachelors Degree is preferred. Advanced Degree in related field is a plus
- 7 - 10 Years; 3 - 5 Years with Masters; 2 - 4 Years with PhD
Experience & background
- This position will require constant collaborative interactions with co-workers across functional groups and departments.
- Strong interpersonal skills, outstanding verbal and written communication skills are essential.
- Project management, clinical operations and/or clinical systems management experience along the software development lifecycle, including requirements/specifications development and user acceptance testing for computer systems are preferred
- Experience working in a global cross-functional team (matrix) environment
- Track record of successful partnership & collaboration with key stakeholders and business partners
- Experience with systems maintenance/improvements and systems integrations in support of business processes
- Good knowledge of clinical systems and processes
- Experience of influencing and negotiating at management level to achieve delivery
- Mastering Microsoft Office suite, proven computer skills and understanding of Information Systems
- Fluent English language skills
Competencies & skills
- “Systems thinking” and understanding of how computer systems support business process/needs
- Good leaderships skills developed through leading successful global multi-functional and/or matrix teams and stakeholder/business partner interactions. May provide guidance and manage work activities of team membersof specific projects or objectives
- Effective stakeholder management: works, communicates and partners with key stakeholders and business partners, both internally and externally
- Has good knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical development, regulatory, etc.
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing cost, time and longer-term objectives.
- With some guidance can manages diverse range of tasks and develops solutions to difficult problems where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact. Regularly uses ingenuity and innovation within this process
- With some guidance can develops solutions to a variety of complex problems and initiatives; ensures solution are consistent with organization objectives
- With limited guidance can determining objectives and approaches to daily work assignments
- Self-motivated, self-starter and achievement driven, works without appreciable supervision
- Excellent time management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
- Good understanding of international regulations, processes and issues in drug development. Includes sound understanding of GCP/GxP and related systems that support clinical trials and clinical operations processes
- Excellent written and verbal communications and interpersonal skills; can influence without authority
- Demonstrates Values & Leadership Competencies