Clinical Operations Lead
1 DNA Way Mailstop 258A South San Francisco, CA 94080 US
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 will have the opportunity to work as needed across one or more areas of PDG including: global study management, patient/disease areas, local country clinical operations, biosample management, 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, talent flow, and other areas.
As a Clinical Operations Lead, your initial responsibilities will include:
- Clinical operations - focused on the US, assisting in operational activities from study start-up through database lock: including feasibility, regulatory document management, systems maintenance, site support and vendor management.
- Local and global initiatives and personal development.
- Over time you will flow to other responsibilities according to business needs and your interest
You exemplify the following:
- Typically established in a career with at least 4 years of relevant experience.
- Has working knowledge of Drug Development and Clinical Operations or related areas of expertise.
- Developing leadership skills, mentoring and coaching colleagues with less experience, and provide guidance; may lead parts of projects.
- Has knowledge of best practices and the role of Clinical Operations in pharma product development; is aware of the place in the market and our value proposition to patients.
- Building subject matter expertise on specific clinical operations activities through supporting the execution of clinical trials and/or enabling projects
- Collaborating across departments and other functions to develop and implement best practices across clinical operations.
- Ability to serve as a resource for colleagues; can work across moderate sized projects with manageable risks and resource requirements.
- Always reflects upon and evaluates reasons behind a particular reason or belief and takes responsibility for the implications of personal thoughts or actions.
- Works in rapid cycles (real-time optimization) to prioritize (i.e., determine what work is essential or kill certain things in order to create the capacity to focus on what matters) and ensure the 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.
- Provides subject matter expertise on specific Clinical Operations activities or through supporting the execution of clinical trials and/or enabling projects across geographies.
- Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives.
- Independently and with minimal guidance develops plans to support the execution of clinical trials and/or enabling projects.
- Collaborates across PDG and other functions in the delivery of the portfolio
- Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
- Has knowledge of other business functions in the organization and learns the upstream and downstream impacts of their teams decisions, including resourcing, on other parts of the business.
- Participates in identifying vendors, builds relationships and partners to ensure 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 us as a preferred partner.
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