Study Start-up Lead (Clinical Pharma)

SRG; Richmond (VA); Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player in the Life Sciences sector is seeking a dedicated Study Startup Lead to play a pivotal role in driving study start-up planning and execution. This fully remote position offers the chance to work closely with a talented pharmaceutical team, ensuring compliance with global regulatory standards and overseeing critical site activation deliverables. With a focus on collaboration and leadership, you will manage multiple projects, lead feasibility assessments, and ensure high-quality deliverables. If you are passionate about advancing clinical research and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in clinical research focused on study start-up activities.
• Proficiency in clinical trial management systems and tools.

Responsibilities

• Lead all SSU activities in collaboration with Clinical Project Manager.
• Oversee execution of site start-up strategies and manage project milestones.

Skills

Clinical Research

Project Management

Team Leadership

Risk Management

Regulatory Knowledge

Education

Bachelor's degree in Life Sciences

Tools

Veeva Clinical Vault

Veeva CTMS

GrantPlan

Job description

SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Study Startup Lead to join our client's pharmaceutical team. This person is accountable for study start up planning, SSU activities and site identification and overseeing the CRO's activation deliverables in compliance with processes, GCP/ICH and regulatory requirements globally. In this role, the Study Start Up Lead will be expected to both plan and execute the startup strategy. This is a fully remote positions with some travel.

MUST HAVES:

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• Minimum of 5 years of experience in clinical research, with a focus on study start-up activities.
• Ability to lead and motivate an internal and external team.
• Proficiency in clinical trial management systems and tools.

• Project Management: Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
• Systems knowledge in Veeva Clinical Vault, Veeva CTMS preferred, and GrantPlan preferred.
• Regulatory Knowledge: In-depth understanding of regulatory requirements and guidelines (e.g., ICH-GCP, FDA, EMA, Health Canada, TGA).
• Risk Management: Ability to identify potential risks and implement mitigation strategies.

JOB RESPONSIBILITIES:

• Leads all SSU activities of assigned projects in close collaboration with Clinical Project Manager as well as the global study team.
• Lead global study feasibility and site identification in close collaboration with the Clinical Project Manager, Clinical Team Manager or Clinical Trial Associate.
• Site Identification and Selection
• Configure and ensure proper trial-specific set-up of SSU systems
• Oversee the execution of site start-up strategies, manage project milestones, coordinate team activities when applicable, and train internal staff in site start-up processes.
• Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects (overseeing the CRO)
• Documentation and ComplianceA
• ccountable for overseeing timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness.

Key Performance Indicators:

• High quality, timely SSU deliverables/documentation/data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority, and SOP requirements.
• Successful site activation within planned timelines.
• Effective supplier oversight, risk management and mitigation strategy

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting [e-mail] or fill out this form to request accommodations.