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Clinical Operations Leader
$1.00 - $1.00
$1.00 - $2.00
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Global Company is hiring a Senior Leader Clinical Operations
Biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Company is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications
This position will be responsible for initiating and leading clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Head of Clinical Operations
Leadership of high profile clinical trials for Rare Disease
Growing Global company- with proven science and products - Energy of a start up but has the stability and NO Volatility
Four new programs in clinical stage this year and launching four more next year
Work with the internal project team and manage the preferred provider CRO team and vendors to plan and implement clinical trials for several new vaccines.
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.
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