Associate Clinical Sciences Trial Leader

Associate Clinical Sciences Trial Leader

Job Description Summary

-Supporting Clinical Scientist for global studies. May serve as Study Leader and/or Clinical Scientist for low complexity global studies or local studies. Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities 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. -

Job Description

Major accountabilities:

• Support the clinical protocol development process in collaboration with line functions of the clinical trial team; 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 and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.
• In collaboration with key cross functional partners, supports identification and selection of strategic and high performing sites to ensure recruitment commitments are met.
• Support a global cross functional CTT to 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.
• 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 reporting clinical study results in CSR.
• Support dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.
• Support risk mitigation discussions, risk management and implementation at the trial level.

Minimum Requirements:

• Approximately 3+ years’ experience in clinical trials/development
• Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
• Creates a positive work environment by inspiring and encouraging mutual respect.
• Demonstrates strong interpersonal skills to build positive relationships.
• Demonstrates tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.
• Embraces a culture of diversity, inclusion, quality and always driving forward with integrity.

Skills Desired

Clinical Research, Clinical Trials, Data Integrity, Learning Design, Risk Monitoring

Experience Level

Mid Level