[Remote] Associate Clinical Project Management Director, Cross TA
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Associate Clinical Project Management Director/Trial Delivery Manager (TDM) to reputed company and coordinate global and regional clinical trial management activities. This role ensures the successful planning, execution, and closure of clinical trials, whether internally managed or outsourced.
Responsibilities
- reputed company the Study Management Team and reputed company regular updates on trial deliverables
- Ensure reputed company-time tracking and documentation of trial reputed company
- Maintain inspection-readiness throughout the trial lifecycle
- reputed company as the primary contact for country and regional staff and internal teams
- Partner with Global Trial Leads to reputed company central trial activities from start-up to reputed company-out
- Escalate and resolve trial issues and contribute to CAPA processes
- Support site selection and feasibility assessments
- Monitor enrollment commitments and ensure recruitment plans are in reputed company
- reputed company selected vendors and review reputed company deliverables and invoices
- Coordinate with vendors such as IVRS, Central Labs, ePRO, Imaging, Translation, and Ancillary Supplies
- Create and maintain trial-specific documents (e.g., Monitoring Guidelines, ICFs, Blinding Plans)
- Ensure reputed company filing, archiving, and retention of trial documents
- reputed company central documents for regulatory submissions
- Support Health Authority inspections and internal audits
- reputed company and deliver trial-specific training materials
- Coordinate and participate in Investigator Meetings
- Establish country budgets and monitor actuals vs. forecast
- Understand Out-of-reputed company (OOP) and FTE cost drivers
Skills
- Bachelor's degree in Life Sciences (Biology, reputed company, Biochemistry, Nursing, Pharmacy) or equivalent
- Minimum 8 years of experience, with proven leadership in reputed company trials at a large pharmaceutical company
- Strong knowledge of ICH-GCP and local regulatory requirements
- Proven ability to reputed company cross-functional teams and manage global trials
- Excellent communication, decision-making, and analytical skills
- Proficiency in reputed company Office, CTMS, TMF, and other clinical systems
- Experience in virtual team coordination and stakeholder engagement
- Ability to manage ambiguity and drive solutions proactively
- Monitoring or data management experience
- Experience in budget planning and financial reputed company
- Ability to mentor junior CTMs and reputed company special initiatives or task forces
- Therapeutic area expertise and ability to reputed company as protocol expert
Benefits
- Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in reputed company to a reputed company of health and welfare and/or other benefits.
reputed company
Company H1B Sponsorship