Job Description

Location - Bengaluru/Mumbai/Hyderabad

As Portfolio Lead, Clinical Programming, this position is responsible for formulating the clinical programming strategy across a set of clinical trial and/or report activities, compound, disease, therapeutic or reporting group area, indication assigned of medium to high complexity. They are accountable for the effective planning and execution of programming activities across multiple clinical trials for their assigned portfolio ensuring effective partnership with, and management of stakeholders.

This position drives operational excellence, consistent implementation of data standards, program and report library templates and macros as programming lead. Accountable for effective resource allocation and utilization of resources as well as optimal assignment of work in accordance with sourcing decisions, people/ partnership development goals and business needs.

This position is responsible for making autonomous leadership decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction technical and project specific guidance to programming teams.

Additionally, they provide leadership and/or expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.

Depending on departmental needs, this position may fulfil the role of a functional manager, where they are responsible for the recruitment, onboarding, performance management and development of people within their reporting line.

As a highly experienced technical Principal Clinical Programming Lead role. They apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to clinical programmers.

Principal Responsibilities:

As Portfolio Lead, Clinical Programming role:

• Accountable for clinical programming strategy across assigned portfolio of medium to high complexity, scope and/or criticality within compound, disease area, indication or Therapeutic Area.
• Responsible for the planning, execution and completion clinical programming activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area.
• Proactively evaluates and manages resource demand and allocation of internal and external team members to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
• Responsible for anticipation, early detection, prevention and management of risks and issues impacting programming deliverables. Effectively manages issue resolution activities, adopting appropriate escalation pathways as needed.
• Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency and knowledge-sharing across projects and programs.
• As applicable, oversees activities outsourced to vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
• Collaborates effectively with team and cross-functional counterparts and vendors to achieve project goals.
• Participates in hands on project or trial initiation activities, as needed.
• Contributes to and/or leads departmental innovation and process improvement projects and development of disease or therapeutic area standards, training as required, may contribute programming expertise to cross functional projects/initiatives.
• Ensures compliance of assigned teams and personnel with company and department SOP\'s, policies and regulatory guidance documents.
• The position mentors and coaches and delegates work.

As functional area people leader:

• Provides leadership by attracting and retaining top talent, managing performance, actively supporting development, and ensuring organizational effectiveness, transparency, and communication. Provides mentorship and coaching to new programming team members.
• Responsible for local administration and decision making associated with the management of assigned personnel.

As highly experienced technical Principal Clinical Programming Lead role:

• Designs and develops technical solutions in support of highly complex/critical clinical programming and report activities, including urgent requests.
• Applies technical expertise to develop solutions that increase efficiency and quality.
• Responsible for adoption of new innovative solutions and processes on assigned areas of responsibility.
• Serves as a departmental resource in areas of technical, scientific and/or disease or therapeutic area expertise.
• Participates in hands on project or trial initiation activities, as needed.
• Contributes to and/or leads departmental innovation and process improvement projects and development of disease or therapeutic area standards, training as required, may contribute programming expertise to cross functional projects/initiatives.
• Ensures continued compliance with required company and departmental training, time reporting and other business processes as required.
• The position trains, mentors and coaches and may delegate work.

Responsibilities for others:

Principal Relationships:

• Reports into people manager position within the Clinical Programming functional area. Accountable to the Associate Director, Portfolio Lead for assigned programming activities and responsibilities.
• Functional contacts within organization include but are not limited, IDAR Therapeutic Area Lead, Data Management Leads, Clinical Data Standards Leads, Process, Sourcing & Compliance Leads, Statistical Programming Leads, Risk Management Central Monitoring.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Global Program Leads, Global Trial Leads, Quantitative Sciences, Biostatisticians, Regulatory, Clinical, BRQC-QP&S, EBIS, Human Resources.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups.

Qualifications

• Bachelor\'s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degree (Master\'s, PhD or equivalent) preferred.
• Approximately 8-10 years clinical programming experience with increasing responsibility OR Masters/MBA in a relevant field and 6-8 yrs. relevant experience OR PhD in a relevant field and 5 yrs. relevant experience. Experience in a pharmaceutical/ clinical trial environment preferred.
• Advanced knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
• Expert CDISC SDTM knowledge.
• Demonstrated project leadership experience managing risks, resources and leading teams to successful outcomes.
• Experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. Working with CROs, academic institutions) preferred experience.
• Strong communication, influencing and negotiation skills.
• As applicable, demonstrated people management skills and experience in staff performance management and people development.
• In depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

eQuest