Clinical Operations Lead (Off-site)

Clinical Operations Lead (Off-site)
100% Remote in CA (PST)/ Remote in South San Francisco, CA
Duration: 12 months+
Pay $60-$80/hr on w2
Shift: 1st (PST hours)
Education: Minimum BS Degree completed

Contract Clinical Operations Lead (cCOL)
Job Description

At Client/Client, we have a Product Pharma Vision to achieve 3-5 times more patient benefit at 50% less cost to society. With this vision top of mind, Pharma Product Development (PD) Global - inventing how we organize ourselves and work. We seek to create new ways of working, always with the patient at the center of everything we do. Our shared purpose is to innovate clinical trial delivery to transform Clients patient, caregiver, and site experience to bring better trials to more patients.

We want you to join our mission and be part of our passionate, collaborative, Global Clinical Operations community! We act as one mutually accountable community focused on work that will have the highest impact on our core mission of helping patients across the industrys most robust Development Portfolio. We recognize the individuality and diversity of everyone, the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional job titles and job descriptions. We believe in reducing hierarchy and silos to enable teams closest to the work to deliver impact for patients. We empower and enable people to deliver on outcomes-based work where there is the most business critical and priority impact in moving towards our Pharma Vision.

If this culture and way of working resonates with you, we want you to be a part of our team!

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.

You exemplify the following:

• 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 Client as a preferred partner.