Start Up Project Manager - FSP

Job Summary

The Start Up Project Manager is responsible for defining, developing and delivery of the Global Study Start Up Project Plan by partnering with Study Manager, Clinical Trial Application Group, in-country Start Up operations colleagues, and others as required for all assigned interventional studies up to 100% sites activated

• Partner with Study Optimization to leverage site intelligence to inform the Start Up Project Plan.

• Partner with the Targeted Investigator Network Strategy Implementation Lead to ensure accelerated start up strategies are leveraged at Targeted sites.

• Partner with Clinical Trial Application and operational Start Up functions to align all country and site activities to Start Up Project Plan

• Identify risks to site activation and develop mitigation plans. This role is also accountable for resolution of Site Activation escalations for Study Teams including offering options for mitigation (both at the study and site level).

• Leader of the Start Up Sub team and a core member of the Study Management Operations Sub team.

• Ad-hoc member of the Core Team Meeting throughout study start up.

Job Responsibilities

Leader of the Site Activation Sub team and a core member of the Study Management Operations Sub team

• Lead the cross functional site activation team – internal plus external as applicable, utilizing the appropriate team members to support implementation of the Start Up Project plan.

• Ensure accelerated Start Up for all sites leveraging the in-country start-up operations colleagues and external colleagues as applicable to ensure all sites are activated and “Ready to Enroll”.

• Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager through the Study Management Operations Subteam with in-country Start Up operations colleagues.

• Ensure alignment to the Decision View Study Optimiser (DVSO) scenario planning.

Accountable for defining, developing and delivery of the Global Study Start Up Project Plan, including:

• Track and communicate with Study Management Operations Subteam & Core Team.

• Drive alignment of in-country start up colleagues to country and site level plans.

• Agree to deliverables on a site-level basis with the in-country start up colleagues and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.

• Use site activation reporting tool following site ID, up to and including, site Ready to Enroll, incorporating input from Directors of Clinical Site Operations to regulatory submission/approval timelines in order to achieve agreed upon milestones in DVSO.

• Implement strategies within Study Start Up Subteam on assigned study to ensure consistent and efficient communications internally and with external colleagues as appropriate.

• Drive the in-country Start Up operations colleagues to manage site activation timelines across all sites to the level of the individual site:

• Understanding critical path activities at the site level

• Ensure planning for individual components of the Investigator Initiation Package documentation (including site contracts and budgets and Informed Consent Document) in partnership with in-country Start Up operations colleagues

• Ensure site readiness activities are considered in the overall timelines for each site to ensure ready to enroll

• Supplies on site (Investigational Product and non-clinical supplies)

• Systems access

• Training (break blind, systems training, etc.)

• Translations

Leverage all available intelligence to inform the Study Start Up Strategy:

• Partner with Site Intelligence to ensure clear communication of data.

• Obtain CTA, Country and Site level input to plans.

Identify risks to site activation and develop mitigation plans, including providing input to SciOps materials:

• Identify and capture key risks to site activation for inclusion in SciOps presentations.

• Develop site activation mitigation plans and monitor effectiveness through Study Start Up Subteam.

Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

Qualifications

Education

• Extensive global clinical trial/study management experience

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• Must have a BS/Nurse – 5 years relevant experience or MS/PhD – 3 years relevant experience

PREFERRED QUALIFICATIONS

• Prior Experience: demonstrated knowledge of site selection, site activation, site readiness interdependencies

• Demonstrated experience leading cross functional teams

• Demonstrated experience in Project Management activities and responsibilities

• Previous vendor oversight experience

Skills

• Technical expertise in the use of Site Activation tools

• Ability to manage complex processes

• Ability to manage in a matrix environment

• Risk Identification & Mitigation

• Strategic Planning, Analytical and Problem Solving Skills

• Critical Path Analysis

• Country level awareness and strong interpersonal skills

• Excellent communication skills, both written and verbal. Must be fluent in English.

• Detail oriented & possesses technical expertise (e.g.,PM tools, Gantt charts spreadsheets, metrics & data flow management)

• Self motivated