Senior Clinical Trial Manager

Job Description

The Senior Clinical Trial Manager will independently manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The assigned clinical trial(s) may be high complexity or high risk. The Senior Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.).
Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs.
Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions.
Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff.

Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.).
Lead the identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs.
Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions.
Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff.

Qualifications

Additional Information

Shyam SherielAssociate Recruiter - Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.507.7514 | Fax: 973.998.2599