Company
ClinicalSciencesTrialLeader
Neural analysis suggests this role is
optimal for Mid candidates.
“Clinical Sciences Trial Leader. Skills: Clinical trial leadership, Protocol development, Operational execution, Data review and interpretation, Budget management, Risk management. Contribute to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. Lead specific aspects of global clinical trial(s)”
What You'll Achieve.
Deliver study outcomes within schedule, budget, quality/compliance and performance standards; Ensure recruitment commitments are met; Minimize variance between actual and forecasted spend
Industry & Context.
Problem solving; Actionable alternatives to accelerate timelines; Risk mitigation; Risk management
What They're Looking For.
Must Have
Bachelors in life science/healthcare, Approximately 5+ years’ experience in clinical trials/development, Proficient in clinical trial methodology with an emphasis in early clinical development, Operational project management experience includes excellent planning, prioritization, problem solving and organizational skills, Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend, Maintain good knowledge of ICH-GCP, external regulations and procedures and track record of successfully managing multiple clinical trials concurrently, Used to managing multiple priorities, Demonstrates ability to drive collaborations through unpredictable circumstances and higher pace changes, leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect and interpersonal skills to build positive relationships
Nice to Have
Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters)
What You'll Do.
Contribute to all aspects of global clinical trial(s) to deliver study outcomes within schedule
quality/compliance and performance standards
Lead specific aspects of global clinical trial(s)
Contribute to operational excellence through process improvement and knowledge sharing
Lead or support the clinical protocol development process
Author clinical protocols
Contribute to the medical/scientific input for study-related documents
Contribute to the development of clinical sections of study-level regulatory documents
Support development of strategic and scientific input into study concept
Develops and implements study-level operational execution plan
Collaborate with key cross functional partners to identify and select strategic and high performing sites
Lead or support a global cross functional CTT
Ensure all trial deliverables are met
promotes realistic planning and timelines
and presents actionable alternatives to accelerate timelines
Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations
Lead or support the ongoing medical/scientific review of clinical trial data
Partners on data analysis and data interpretation
including safety trend analysis
development of first interpretable results
reporting clinical study results in CSR
and internal/external publications
lead or support dose escalation meetings with investigators
Coordinate the real time availability of quality clinical trial data
Proactively lead or support risk mitigation discussions
risk management and implementation at the trial level
Responsible and accountable for forecasting and managing overall study budget(s)
Collaborate with key partners to set vendor strategy and timelines
Responsible for implementation of best practices and standards for trial management
including sharing lessons learned
Represent group on may serve as Subject Matter Expert
Contribute to talent and career development of staff
Contributes to hiring/interview/onboarding and mentoring process for new hires
How You'll Work.
Team & Collaboration
Core member of the Clinical Trial Team; Collaborate with the Medical Lead and other line; Collaborate with key cross functional partners; Partner with line functions to gain input and alignment; Manages internal and external stakeholder expectations; Collaborate with the medical expert and key line functions; Collaborate with key partners
Communication Scope
Interpersonal skills to build positive relationships
Process & Methodology
Operational project management, Excellent planning, Prioritization, Problem solving, Organizational skills, Project Planning, Waterfall Model
Full Job Description
**Job Description Summary** Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing **Job Description** **Key Responsibilities** * Lead or support the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents. * Support development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable. * Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met. * Lead or support a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines. * Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations. * Lead or support the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on * data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications. * Prepare, lead o
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