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Associate Director, Clinical Operations
147544
Posted:
30/07/2024th
30/07/2024
- 170000 USD - 200000 USD
- San Francisco , United States
- Permanent
Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. Reporting to the Head of Clinical Operations, the Senior Manager/Associate Director, Clinical Operations will be accountable for the day-to-day operational oversight of at least one clinical trial in all Regulatory phases, including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This individual will have cross-functional leadership responsibilities.
RESPONSIBILITIES:
- Manages clinical operations trial activities for assigned clinical studies
- Responsible for all aspects of day-to-day clinical trial execution; must be comfortable with taking on additional responsibilities when needed
- Responsible for overall study project management of clinical trial(s) including:
- Projection and management of study timelines
- Creation and management of clinical trial budgets, in conjunction with line manager
- Ensures timely reporting of study metrics to line manager and/or executive management
- Manages the CRO and any supportive vendors
- Identify and manage the activities of clinical CROs and other clinical study providers (central labs, EDC providers, patient recruitment vendors, etc.) to ensure studies are completed within agreed upon timelines and budget
- Serves as primary contact for the CRO, and functional area representatives involved with the trial execution
- Ensures corporate goals are effectively communicated and operationalized within the internal and external study teams
- Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to line manager
- Leads and facilitates cross-functional study execution team (SET) meetings, responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of action items and meeting minutes
- Partner with clinical investigators, site staff, patient advocacy and referral groups to ensure that study goals are met
- Contribute to the preparation and management clinical trial budgets, timelines and resource requirements
- Recruit, manage and provide leadership and guidance to direct reports assigned to clinical studies
QUALIFICATIONS:
- BS or MS degree with 7-10 years’ experience in clinical operations, with 5 years’ experience in clinical study management in the pharmaceutical or biotech industry
- Experience working at a small biotech as a clinical study lead is required
- Experience creating processes from the ground up is required
- Extensive experience in autonomously managing Ph I-III clinical trials is required
- Extensive clinical operations knowledge and cross-functional understanding of clinical trial methodology
- Experience in global clinical trial operations is strongly preferred
- Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Strong communication skills both oral and written are a must
- Organizes and prioritizes numerous tasks and completes them under time constraints
- Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques
- Excellent organizational and analytical skills are required
- Demonstrated success in problem solving
- Experienced professional with a full understanding of area of specialization
- Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for the position
The salary range for this position is $170,000 - $200,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.
Leila Johnston
Division Director