The Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross-functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans.
The Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the Program Operations Lead and other key stakeholders informed of status, risks, and mitigations. Activities include but are not limited to:
-Protocol development with other key functions including medical, regulatory and statistics; management of medical writing activities for protocols and other key study documents eg, Investigator Brochures, Informed Consent Forms, and Clinical Study Reports.
-Oversee the study feasibility process and develop country and site plans for clinical studies.
-Development of study operational strategies including vendor outsourcing approach.
-Selection and management of CROs and third party vendors in line with study and program goals; review and approval of study plans and documents.
-Management of study level budgets.
-Ensure effective clinical and safety data review plans are developed and followed throughout the study; develop and oversee implementation of corrective actions to support good data quality.
-Oversee the multifunctional team and manage vendors to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans.
-Development and maintenance of in-house operations SOPs, guidelines and systems; ensure studies are in compliance with ICH GCP and relevant in house procedures.
-Ensure complete and inspection ready eTMFs throughout the duration of clinical trials
-BA/BS in a clinical or scientific discipline; at least 6 years of experience with clinical trials; at least 3 years working with a sponsor company (biotech/pharmaceutical company). Additional experience in other related fields or positions is a plus. Some phase 2/3 and global clinical trial experience required.
-Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
-Protocol, informed consent form, and clinical study report writing experience preferred.
-Excellent leadership, interpersonal, project management, and communication skills.