Clinical Study Manager/ Clinical Project Manager
- Expired: over a month ago. Applications are no longer accepted.
The duties for a full-time position include:
a. Lead organization of data-collection, cleaning and listing of the clinical trials.
b. Assist in the analysis and planning of the Company's clinical trial data, development of project timelines, engagement with external stakeholders, accounting, and development of presentations in accordance with the Company's overall drug development program objectives; Prepare high-quality deliverables within established timelines and budgets.
c. Assist Statistical consultants in data-organization, insights, presentations by creating general program oversight and assist the management across clinical programs within Deka's drug development
d. Support the organization of the Company's clinical trials with Clinical Research Organizations (CROs) and other vendors, as well as institutional partners, and implement effective processes, including contingency plans, to execute clinical trials in accordance with company objectives.
e. Ensure operational excellence by applying high industry standards, policies, systems, and processes across all clinical trials. Ensure that documentation from investigators and clinical sites meet U.S. Food and Drug Administration (FDA), Good Clinical Practice (GCP), and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
f. Support the management and oversight of clinical operations for all study activities including the development of study protocols, informed consent forms, study plans and manuals, case report forms, Ethics Committee (EC)/Institutional Review Board (IRB) submissions, charters, patient recruitment, clinical study monitoring, clinical compliance/Standard Operating Procedures (SOPs), safety evaluations, preparation of statistical analysis plans and clinical study reports. Assist the Company's clinical operations team with support for data management and biostatistics as needed.
g. Assist site coordinators and CROs, and serve as a resource to site coordinators and investigators, monitor and track progress, and respond to day-to-day matters.
h. Oversee site monitoring visits and meet with site coordinators and field clinical staff.
i. Create monitoring plans, coordinate Investigational New Drug Application (IND) filings with Company's vendors, coordinate communications with the FDA and CROs, oversee study reports, and assist in developing sections for investigator brochures and clinical sections of regulatory documents.
Specific tasks will include the following, as well as any other duties and assignments to be assigned by the Company's CMO:
a. Orchestrate data management and institutional relations needed for opening first clinical trial
i. Assist in, development of project timelines, engagement with external stakeholders,
accounting, and development of presentations in accordance with the Company's
overall drug development program objectives.
ii. Propose efficiencies across future programs.
b. Periodic Review of Product Risk Analysis
i. Create portfolio oversight with timelines.
ii. Create framework for clinical trial monitoring, analysis expectations and timeline
iii. Monitor IND filing progress and risk.
a. Start documentation on needed data collection, monitoring, vendor interactions, FDA reporting
organize internal external communications around trial management.
b. Create management tools for vendor negotiations, including CROs, and suppliers, and
budget/contracts with preclinical and clinical trial sites.
4. Quality Plan
a. Assist in the development and documentation of Standard Operating Procedures (SOPs) for clinical trial management, data collection, safety monitoring and other operations.
a. Prepare high-quality deliverables within established timelines and budgets.
b. Negotiation/contracts for vendors, consultants, and sourcing partners
c. Oversee data-base management, CRO work, organization, and documentation of DSMCs
d. Project Timelines/Scenarios
e. Clinical trial management, costs and timelines
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