Manager, Clinical Operations

Duration: 12 Months+

• Manage one or more small study(ies) or support large study teams by overseeing execution according to ICH/ GCP guidelines and SOPs/SWPs.
• Monitor and track studies against defined milestones & budget and facilitate the development and implementation of remedial activities when necessary.
• Coordinate with cross functional teams internally and vendor teams to ensure key study documents (e.g., protocols, case reports forms, informed consent documents, study management plans and final clinical study reports) and other deliverables are timely met.
• Manage clinical vendors, ensuring selection of high-quality vendors, negotiating contract terms and overseeing adherence with regulatory requirement.
• Proactively recognize problem situations and resolve them.
• Proactively monitor and report clinical trial status.
• May assume site co-monitoring responsibilities.

Qualifications:

• Bachelor’s degree in biological science, nursing, pharmacy or equivalent area.
• At least 4+ years of experience managing/ leading multiple clinical trial project teams and vendors.
• Experience coordinating/ collaborating with cross functional drug development teams and site teams.
• Experience contributing to clinical trials process improvement initiatives.
• Significant experience working with regulatory & compliance standards/guidelines including ICH-GCP.

Proficiency Level Descriptors:

• Expert Is considered an organizational expert and is able to envision and define breakthrough solutions/ processes based on deep expertise.
• Advanced Leverages advanced knowledge/ skills within area to identify and implement new/improved processes.
• Proficient Demonstrates strong knowledge/skills within area on a consistent basis to solve complex problems independently.
• Intermediate Is able to apply knowledge/skills within own area to deliver tasks with limited guidance.
• Developing Is learning skills on the job and applies knowledge in routine tasks and activities. Delivers under supervision and guidance.

Budget Management Intermediate:

• Demonstrates a good understanding of budget planning and tracking tools & processes as well as related internal
• policies and procedures.
• Tracks, reconciles and reports budget for own area, highlighting any deviations and escalating as needed.
• Communicates with other teams to drive budgeting processes, collecting information and sharing reports.

Clinical Trial Management Proficient

• Leverages knowledge of trial and study management to create project plans for own area, based on overall scope and timelines of the study; acts as a point of contact.
• Understands study interdependencies, and consistently communicates with critical stakeholders to drive execution, escalating as needed.
• Identifies improvement opportunities for own area, based on deep understanding of systems, process and regulations related to clinical trial management.
• Communication & Cross-functional Influence Intermediate
• Effectively communicates within own team and cross functionally and presents insightful messages (in writing or verbally).
• Engages with other teams to seek/offer support for best outcomes.
• Contributes in meetings, facilitates as needed, raises concerns and shares information with team.
• Critical Thinking & Business Agility Proficient
• Able to draw insights from different sources of information/data and quickly draw meaningful conclusions.
• Solves problems quickly by identifying the root causes.
• Encourages others to see the opportunities with changing business landscape, even when the details have not been finalized.

Industry/ Regulatory Knowledge Proficient

• Proactively keeps track of changing regulatory and quality standards to align processes for compliance within own area.
• Effectively monitors compliance with regulatory requirements and reports issues.
• Demonstrates an understanding of pharma industry, company strategy, product & pipeline and competition and how that applies to own function/ department.

Mentoring/ People Development Developing

• Guides others in their own team in technical areas to help them grow and develop.
• Frequently gives actionable feedback with concrete evidence and the right kind of message tone.
• Stays open to feedback.

Vendor Management Proficient

• Participates in vendor evaluation processes based on a clear understanding of business needs and requisite vendor capabilities.
• Monitors vendor performance against desired outcomes and proactively collaborates with vendor teams to pre-empt and resolve potential issues.
• Negotiates vendor contracts while looking for synergies within own function/ department and ensures compliance with regulations and policies.

Shift: Day