Lead the Clinical Study Team to drive effective decision making
SMCI is seeking a Early Development Clinical Trial Manager to be the primary point of contact to lead, manage and co-ordinate the conduct of Phase 1/1b clinical trials from study design to close out at a global level in accordance with ICH-GCP.
This position may be assigned to a client that requires all individuals on-site to have the COVID-19 vaccination. The individual must be fully vaccinated before starting work at such a client site.
Develop early phase clinical operation strategy and contributes to the strategic scenario planning in clinical development plan
Oversee the quality and scientific integrity of clinical operations for early development studies at a global level
Lead study level planning of the overall clinical operation, execute day-to-day operations of clinical trial at a global level and resolve issues escalated by the local study team
Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
Manage vendors to the required standards
Contribute to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report.
Required Skills: Biopharma Clinical Research; Clinical Trials.
Don't hesitate! Submit your resume today.
SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm.
(No third parties, please)
(H1 sponsorship currently unavailable)
(Local candidates only, please)