Description
Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster.
The Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices.
Essential Functions:
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project's lifecycle.
- Work strategically to realize clinical project goals including setting and developing clinical strategies.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC).
- Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
- Collaborate with the clinical team to support milestone achievements.
- Resourcing and Talent Planning of the clinical team.
- Conduct regular team meetings and communicate appropriately to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- Contribute to the development of the clinical delivery strategy for business proposals.
- Mentor and coach new peers as they assimilate into clinical lead roles.
Qualifications:
- Bachelor's Degree in Health care or other scientific discipline
- Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Requires consolidated knowledge of Project Management practices and terminology.
- Requires high proficiencies in using systems and technology to achieve work objectives.
- Requires good knowledge of project finances.
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.
- Communication - Strong written and verbal communication skills including good command of English language.
- Problem solving - Problem solving skills.
- Organization - Planning, time management and prioritization skills.
- Prioritization - Ability to handle conflicting priorities.
- Quality - Attention to detail and accuracy in work.
- Results-oriented approach to work delivery and output.
- Leadership - Good influencing and negotiation skills.
- IT skills - Good software and computer skills, including Microsoft Office applications.
- Collaboration - Ability to establish and maintain effective working.
- Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
Salary: The potential base pay range for this role, when annualized, is $106,100.00 - $295,500.00.