Assistant Manager - Clinical Site Operations Gurgaon

Job Description

Primary Job Function:

This position is responsible for the supervision of a team of personnel within Clinical Site Operations which has global responsibilities (all regions). Assists management in hiring, training, developing, and retaining qualified staff for Clinical Site Operations. In addition, this position supports work during the lifetime of Abbott clinical trials including start-up, conduct and closure working independently with minimal guidance, direction and ensuring compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures.

The Assistant Manager will also be directly responsible for managing clinical device movements for clinical trials globally as assigned. Including clinical inventory management with site and local warehouse liaison between site, global project management, Global Device Accountability team, local warehouse, and local customer service as needed and managing import and export processes per local regulations and applicable Abbott work instructions and SOPs.

Core Job Responsibilities:

• Responsible for the supervision of a team of personnel within Clinical Site Operations that support services globally.
• Assists management in hiring, training, developing, and retaining qualified staff for Clinical Site Operations.
• Supports work during the lifetime of Abbott clinical trials including start-up, conduct and closure working independently with minimal guidance, direction and ensuring compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures.
• Able to solve complex problems consider alternative or new perspectives using existing tools and standard processes.
• Functional oversight within Clinical Site Operations covers one or more teams such as Global Clinical Study Payments, Site In-house Clinical Research Associates, Clinical Study Coordinator, Global Device Accountability, Clinical Contracts and/or Global Clinical Budgets under oversight of US and EMEA Site Operations Leadership.
• Responsible for managing clinical device movements for clinical trials globally as assigned. Including clinical inventory management with site and local warehouse liaison between site, global project management, global Device Accountability team, local warehouse, clinical device reporting and local customer service as needed and managing import and export processes per local regulations and applicable Abbott work instructions and SOPs.

Position Accountability/Scope:

u00B7Functional oversight and people management including resource and project assignment oversight (up to 15 direct reports)

u00B7Managing clinical device movements for clinical trials globally as assigned

u00B7Responsible for hiring and training staff, mentoring. Establishing and maintaining function-specific processes and procedures.

u00B7Ensure clinical trial deliverables are met by team and support escalations and consultation with Clinical Quality as needed to resolution.

u00B7Participate and/or lead cross functional process improvement projects as required representing Clinical Site Operations or function within Site Operations.

u00B7Navigate corporate (new or changing) procedures and the impact to Clinical Site Operations. This role is expected to partner with Managers and Directors within Clinical Site Operations organization to align work assignments for team by function and/or site support to ensure clinical trial deliverables are met.

Minimum Education:

Required: two-year degree or equivalent experience, with at least 5 years people management.

Preferred 4-year college degree and 5 or more years of clinical research experience, 2 or more years of people management.