Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
Clinical Operations Lead
Type: Contract, W2 only
Duration: 12+ months
Location: South San Francisco, CA
Pay: $61/hr-$80/hr, DOE
Working Model: multiple openings – hybrid (3 days in office, 2 days remote) and fully remote.
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
A leading Global Biotech Company is seeking a Clinical Operations Lead. As a Clinical Operations Lead in a cross-functional, matrixed organization, you will be empowered to work with people across Product Development Group 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.
Responsibilities:
- Clinical operations: contribute to operational activities that enable trial execution and delivery of the Product Development portfolio of clinical studies and programs across Disease Areas by providing operational and/or strategic input to the teams.
- Ensure adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
- 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.
- Apply organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operations' programs, studies, and/or enabling projects.
- Build 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.
- Work 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.
- Adopt and foster changes and be a change agent for investigators/patients to adopt new digital technologies in conducting clinical studies.
- Identify, contribute to and participate in continuous improvement and change management activities to solve complex problems and bring new perspectives. Independently and with some guidance develop 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 the company as a preferred partner.
- Other responsibilities according to business needs and priorities.
Qualifications:
- At least 2 to 5 years of relevant experience.
- Knowledge of Drug Development and Clinical Operations or related areas.
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.