Clinical Operations Lead

TalentBurst, an Inc 5000 company; South San Francisco (CA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

A leading clinical operations firm in South San Francisco seeks a Clinical Operations Lead to drive trial execution and ensure compliance with regulatory guidelines in a hybrid work environment. The ideal candidate will have 2-5 years of relevant experience, strong problem-solving skills, and the ability to thrive in collaborative settings. Responsibilities include contributing to operational activities and supporting quality compliance while promoting best practices in clinical operations. Join a team that fosters growth and innovation to advance clinical trials for patients.

Qualifications

• 2-5 years of relevant experience in clinical operations or drug development.
• Ability to thrive in collaborative and ambiguous environments.
• Experience with ICH, GCP, and regulatory guidelines.

Responsibilities

• Contribute to operational activities enabling trial execution.
• Promote and support quality and compliance in clinical operations.
• Collaborate across functions to implement best practices.

Skills

Drug Development Knowledge

Clinical Operations

Problem-Solving Skills

Effective Communication

Organizational Skills

Job description

Overview

Working Model: Hybrid, South San Francisco, CA (Three days in office, Two days remote)

12 Months

Summary:

As a Clinical Operations Lead in a cross-functional, matrixed organization, you will be empowered to work with people across PDG and beyond to enable all teams to perform at their best, foster a growth mindset to optimize potential and talent, and flow to high impact work to advance our medicines for patients. You may have the opportunity to work as needed across one or more areas of PDG including: study management, patient/disease areas, biomarker operations, quality management, systems and process development, learning, insights and analytics, as well as strategic focus areas, such as innovation & creativity, investigator centricity & partnering, patient & caregiver benefit, inclusive research, diversity & inclusion, and other areas.

As a Clinical Operations Lead, your responsibilities will include as directed:

• Clinical operations - contribute in operational activities that enable trial execution and delivery of the PD portfolio of clinical studies and programs across Disease Areas by providing operational and/or strategic input to the teams.
• Local and global initiatives
• Other responsibilities according to business needs and priorities
• Promote and support quality and compliance by being accountable for gcp/gvp compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.

Qualifications

• At least 2 to 5 years of relevant experience
• Knowledge of Drug Development and Clinical Operations or related areas
• Ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
• Thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.
• Apply organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operations' programs, studies, and/or enabling projects.
• An effective communicator that shares information transparently and strategically; comfortable working out loud and is an active listener.
• Building subject matter expertise on specific clinical operations activities through supporting the execution of clinical trials and/or enabling projects across geographies Collaborating across PDG and other functions to develop and implement best practices across clinical operations and delivery of the portfolio.
• Ability to serve as a resource for colleagues; can work across moderate sized projects with manageable risks and resource requirements.
• Works in rapid cycles (real-time optimization) to prioritize (i.e., determine what work is essential or proposed to stop in order to create the capacity to focus on what matters) and ensure alignments of priorities to the mid- and long-term outcomes.
• Fast adoption, foster changes and being change agents for investigators/patients to adopt new digital technologies in conducting clinical studies.
• Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives. Independently and with some guidance develops plans to support the execution of clinical trials and/or enabling projects.
• Work closely with Investigator and clinical site staff with a continuous focus on partnership and aiming to position as a preferred partner.