Extensive global clinical trial/study management experience

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

Must have a BS or BS Nursing and 5 years relevant experience or MS/PhD and 3 years relevant experience

Prior Experience Preferred:

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 CRO 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

The Study 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, Site Activation Partners, CRO Study Start Up and Site Relationship Partners and others as required for Phase 3 and other supported studies.

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 CRO 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 Study Start Up Subteam and a core member of the Study Management Operations Subteam.

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

Accountable for start up of sites to be Ready to Enroll.

Role responsibilities

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

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

Ensure accelerated start-up for Targeted Investigators leveraging the Site Relationship Partners and Site Activation Partners
Drive delivery of all Targeted and CRO supported sites that are “Ready to Enroll” to the Start Up Project plan.

Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager through the Study Management Operations Subteam with the CRO.

Oversee and drive execution of study start-up activity at CRO.

Ensure alignment to the 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 CRO study start up plan to country and site level.

Agree to deliverables on a site-level basis with the CRO 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 DCSO 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 the CRO.

For PFE Targeted Investigators, drive the Site Relationship Partners to manage site activation timelines across targeted investigators to the level of the individual site:

• Understanding critical path activities at the site level
• Ensure planning for individual components of IIP documentation (including site contracts and budgets and ICD) in partnership with CRO Start Up and/or Site Activation Partners
• Ensure site readiness activities are considered in the overall timelines for each site to ensure ready to enroll
• Supplies on site (IP 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 CRO, CTA, Country and Targeted 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

Non-standard work schdule, travel or environment requirements

Remote (home) based position

Limited international travel required (2-3 times/year)

LI-PFE

Sunshine Act

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EEO & Employment Eligibility

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