All Of Our Groups
Healthcare
AssociateDirector,ClinicalDevelopmentTrialLead(CDTL)
“Associate Director, Clinical Development Trial Lead (CDTL) at All Of Our Groups. Skills: Clinical trial leadership, Project management, Cross-functional team leadership. Lead cross-functional study team. Develop clinical trials”
What You'll Achieve.
Deliver clinical milestones on time; Deliver clinical milestones within scope; Deliver clinical milestones within budget
Industry & Context.
Issue identification; Issue resolution; Problem solving; Root cause analysis
Periodic travel
What They're Looking For.
Must Have
5 years clinical trial experience, Working knowledge of clinical research process, Prior clinical trial site-level experience, Prior affiliate experience, Prior experience with local/country regional requirements
Nice to Have
Broader responsibilities at Therapeutic Area/ Molecule/Indication level, Prior experience with TPO qualification process, Prior experience with CRO clinical development point of contact
What You'll Do.
Lead cross-functional study team
Develop clinical trials
Execute clinical trials
Deliver clinical milestones
Develop enrollment plan
Network with business partners
Coordinate Investigator Study Specific Training
Drive study team execution
Manage enrollment strategy
Execute enrollment strategy
Achieve regional enrollment goals
Resolve operational problems
Resolve business problems
Evaluate issues for escalation
Identify continuous improvement activities
Make timely decisions
Manage TPO qualification
Serve as CRO point of contact
Influence study design
Influence program-level decisions
Recognize inter-relatedness of activities
Understand project decision impact
Expand clinical trial process expertise
Make decisions on process
Make decisions on issues
Facilitate obtaining regional input
Manage Trial Master File
Ensure inspection readiness
Create issue summary documents
Anticipate trial issues
Anticipate regional issues
Identify process breakdown areas
Propose innovative approaches
Share process learnings
Act as coach for peers
Act as coach for new CDTLs
Act as coach for team members
Act as coach for TPOs
Lead process improvement activities
Act as CDTL SME resource
Develop new processes
Rollout new processes
Develop new methodologies
Rollout new methodologies
How You'll Work.
Team & Collaboration
Cross-functional study team; Business partners; Vendors; Affiliates/regions; Global team members; Functional record owners; External partners
Communication Scope
Provide consultation; Provide guidance; Report status
Process & Methodology
Project management skills, Project management processes, Project management tools, Critical Chain, MS Project
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