Job DescriptionThe SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies.
Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. If assigned as the study strategy leader, is a key member of the Clinical Study Team representing CSM globally from study planning to close out. If assigned to area site execution activities, responsible and accountable for directing site monitors in a matrix environment and serve as a liaison and primary contact between site monitors, the study strategy leader, and the Clinical Study Team.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
- Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM.
Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones.
Accountable for study level site monitoring strategy, documented in Site Monitoring Plan.
Accountable to set and lead Site Engagement Strategy. - Ensure study-level and/or area-level timelines are maintained across the study lifecycle.
Provide timely and essential study information for country-level teams to execute milestones.
Drive site-level activities at study level and/or area level, including site selection, activation, site engagement, protocol adherence and close out. - Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable.
Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan.
Ensure sites are closed per Site Closure Plan. - Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
- Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
Ensure site compliance, escalate issues, and analyze trends for continuous improvement. - Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts
- Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level
Qualifications- Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- A minimum of 5 years + of industry clinical research experience including 2 year of monitoring or project management or equivalent experience on a global study.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
- Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
- Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
- Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
- Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
- Able to work well within a team and autonomously. Thinks proactively.
Strong ability to create and deliver presentations. - Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
