Senior Manager Program Data Delivery

amgen; Hyderabad; Hybrid; INR 2,500,000 - 5,000,000; Full time

Job summary

Amgen seeks a Program Data Delivery Senior Manager to lead data delivery across multiple studies, ensuring database readiness, data cleaning, reconciliation, and lock execution with cross-study cohesion.

You will mentor Study Data Delivery Leads and Central Monitors, drive best practices, chair program reviews with Clinical Operations, Biostats, Safety, Systems, and vendors, and ensure timely risk mitigation.

Qualifications

• End-to-end management of study deliverables, budgets, timelines, and KPIs to optimize trial execution.
• Identify operational risks based on protocol design and implement mitigation strategies.
• Oversee study budgets and financial operations, approving site expenditures and allocating resources for cost efficiency.
• Interpret clinical and operational data to guide trial execution and ensure data integrity.
• Identify opportunities for continuous improvement in team practices.
• Oversee external vendors (CROs, labs, imaging vendors) to meet deliverables with high quality.
• Develop and train teams related to clinical trial materials to ensure protocol compliance and best practices.
• Drive and execute change initiatives ensuring adoption of new designs within function.
• Mentor professionals across functions and geographies to enable collaboration and trial success.

Responsibilities

• Build and maintain the program data delivery plan across all studies and milestones.
• Standardize program practices for data management and reconciliation procedures.
• Lead Study Data Delivery Leads and Central Monitors; provide direction and review performance.
• Review program metrics and ensure follow-through on actions and risk mitigation.
• Chair program-level issue reviews and coordinate cross-functional resolutions with operations, biostatistics, safety, systems, and vendors.
• Coordinate resources to keep critical paths green, including surge support where needed.
• Consolidate risk registers and track mitigation plans to closure.
• Prepare program status for governance with key decisions and trade-offs.
• Mentor study-level leadership on planning, communication, and stakeholder management.

Skills

Deliverables mgmt

Operational risk mgmt

Budget oversight

Data interpretation

Continuous improvement

Vendor management

Team development

Change management

Mentoring teams

Communication

Education

Doctorate Degree

Master’s Degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Career Category

Clinical Development

Job Description

Role Description

The Program Data Delivery Sr Manager p rovide s program-level oversight and accountability for data delivery across multiple studies, ensuring alignment and consistency in database readiness, data cleaning, reconciliation, and lock execution. This role ensures cross-study cohesion and serves as the accountable data management voice at the program level.

The Sr Manager m anage s and mentor s a pod of Study Data Delivery Leads and Central Monitors, setting expectations, driving adoption of best practices, and ensuring performance consistency across the program to elevate quality and efficiency across the entire portfolio. This role a ct s as the escalation point and strategic advisor for study-level data issues, balancing tactical resolution with a program-wide perspective.

Roles & Responsibilities:

• Build and maintain the program data delivery plan covering all studies, key milestones, and inter-study dependencies.

• Standardize program practices for DMP, IDRP, query management, reconciliation, and lock procedures.

• Lead Study Data Delivery Leads and Central Monitors; provide direction, review their performance, and align their execution.

• Review program metrics (database build progress, query burden, reconciliation status, risk signals) and ensure actions have appropriate follow-through, actions, and closure.

• Chair program-level issue reviews and coordinate cross-functional resolutions with Clinical Operations, Biostats, Safety, Systems, and vendors.

• Coordinate program resources and surge support, including associates and FSPs, to keep critical paths green.

• Consolidate program risk registers and ensure mitigation plans are tracked to closure.

• Prepare program data delivery status for governance, highlighting risks, decisions, and trade-offs.

• Mentor study-level leads on planning, communication, stakeholder management, and overall execution.

Basic Qualifications and Experience:

• Doctorate Degree and 2 years of life science, computer sciences, business administration experience OR

• Master’s Degree and 6 years of life science, computer sciences, business administration experience OR

• Bachelor’s degree and 8 years of life science, computer science, business administration experience OR

• Associate’s degree and 10 years of life science, computer science, business administration experience OR

• High school diploma / GED and 12 years of life science, computer science, business administration experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Experience:

• 7 years work experience in life sciences or medically related field, including 5 years of managing data on biopharmaceutical clinical research experience

• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials

• Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)

• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management

Functional Competencies:

Must-Have Competencies:

• Demonstrates ability for end-to-end management of study deliverables, budgets, timelines, and performance metrics (KPIs) to optimize trial execution.

• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.

• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies.

• Interprets clinical and operational data to guide trial execution and identify study trends. Collaborates with biostatistics and data management to ensure data integrity.

• Able to identify and implement opportunities for continuous improvement into the team's working practices.

• Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality.

• Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices.

• Experience driving and executing change initiatives ensuring adoption of new designs within function.

• Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success.

Soft Skills:

• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally.