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 or 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.
• 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) in collaboration with key partners.
• Collaborate with key partners to set vendor strategy and timelines for assigned studies.
• Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert.
• Contribute to talent and career development of staff. In collaboration with the relevant manager, contributes to hiring/interview/onboarding and mentoring process for new hires.

Essential Requirements

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).
• 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 strong interpersonal skills to build positive relationships.

 

Skills Desired

Auditing, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management, Health Sciences, Lifesciences, Project Planning, Vendor Management, Waterfall Model