Clinical Operations Lead

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Operations Lead for a contract assignment with one of our premier Pharmaceutical services clients in South San Francisco, CA.

Responsibilities :
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.

• 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
• Promote and support quality and compliance by being accountable for Google Cloud Platform/gvp compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.
• 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.
• 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 the firm as a preferred partner.
• Ensures adherence to ICH, Google Cloud Platform, and regulatory guidelines within clinical trials or enabling activities.
• Other responsibilities according to business needs and priorities

Required Skills:

• At least 2 years of relevant experience
• Knowledge of Drug Development and Clinical Operations or related areas
• 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 Operation's programs, studies, and/or enabling projects.
• An effective communicator that shares information transparently and strategically; comfortable working out loud and is an active listener.
• 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.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.