WEP ClinicalRemote
Associate Director, Project Management (Clinical Research)
United States of America
Full Time
2 hours ago
Visa Sponsor
Key skills
Clinical researchExpanded Access ProgramsClinical trial managementLine managementMicrosoft OfficeeTMFCTMSClinical research processICH GCP guidelinesRegulatory complianceData processingElectronic data captureProject managementGCPProject Management
About this role
WEP Clinical is a growing company in the pharmaceutical industry, seeking an Associate Director of Project Management to oversee critical projects and bring life-changing treatment solutions to patients. The role involves leading the project management team, ensuring compliance with regulations, and managing program delivery and budgets.
Responsibilities:
- Lead and oversee the project management team, including training, development, and performance reviews
- Ensure project teams manage programs in accordance with WEP Clinical SOPs, policies, and regulatory requirements
- Oversee regional and global programs, ensuring successful delivery on time and within budget
- Develop and monitor program plans, timelines, and budgets in compliance with Statements of Work (SOW)
- Identify, evaluate, and mitigate program risks, communicating issues to management and clients as needed
- Support Business Development, Contracts, and Finance teams with contracts, change orders, invoicing, and proposals
- Maintain knowledge of US, UK, EU regulations, GxP/ICH guidelines, and ensure GMP/GDP, GCP/ICH compliance
- Document and update internal processes, SOPs, and working practices for consistency across programs
- Produce performance reports for Senior Management and build strong client relationships
- Lead issue resolution, identify new client opportunities, and support vendor evaluation and selection
Requirements:
- Bachelor's Degree (in a health or science field preferred)
- 5+ years' experience in clinical research or project management, with at least three (3) to four (4) years direct clinical trial or Expanded Access Programs experience in a CRO or research related organization with at least one (1) year line management experience
- Computer literacy and proficiency in Microsoft Office, as well as experience with an eTMF and CTMS
- Ability to handle confidential information with complete discretion
- Ability and willingness to travel up to 20% of the time
- Knowledge of clinical research process from Phase I through regulatory submission
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to set baseline targets, track trends, and implement mitigation plans
- Understanding of basic data processing functions, including electronic data capture
- Working knowledge of current ICH GCP guidelines