Country Study Start Up Specialist II

Planet Pharma; North Chicago (IL); On-site; USD 72,000 - 85,000; Full time

Job summary

Planet Pharma in the United States is seeking a Specialist, Country SSU to drive start-up and maintenance activities for assigned studies and sites. You will collect essential documents, coordinate regulatory submissions, ensure ALCOA data quality, and track start-up KPIs while collaborating with cross-functional teams to meet activation timelines.

You will train and mentor junior Specialists, maintain Vault SSU data, and ensure compliance with ICH/GCP guidelines across the country.

Qualifications

• Minimum 3–5 years of clinical research experience; 1+ years in start-up management preferred.
• Experience working with remote/virtual teams and cross-functional partners.
• Solid understanding of ICH and GCP guidelines and regulatory environments.

Responsibilities

• Ensure on-time, high-quality start-up and maintenance activities for sites and studies.
• Collect essential documents and perform ALCOA quality checks.
• Coordinate regulatory submissions and ICF customization; track activation status and KPIs.

Skills

Clinical start-up management

Remote/virtual teamwork

Documents & ALCOA quality

Regulatory compliance

Stakeholder communication

Education

Bachelor’s Degree in health care or scientific field

Tools

IXRS system

Vault SSU

Job description

Target PR Range: 52-62/hr
*Depending on experience

Purpose

The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries:

Responsibilities

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs. Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Attend regional/area start up calls and provide input for assigned sites/studies. Collection of essential documents from sites and completing quality check(ALCOA).
• Compile and submit ethics and other required local document packages including customization of ICFs, patient facing materials and safety reporting.
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
• Collaborate with contract manager, Site Monitor, Area CSM Lead as required to assure timely site activation. Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
• Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
• Maintain local country and site intelligence database and EDLs in Vault.
• Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
• Participate in process improvement initiatives as required.
• Train and mentor new Specialists, Country Start Up

Qualifications

• Bachelor’s Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
• A minimum of 3-5 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
• Experience working with remote/virtual teams
• Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
• Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast?paced environment.
• Working knowledge of ICH and GCP guidelines and operational understanding of the country’s regulatory environment.

*CO/NYC candidates might not be considered