Site Activation Specialist at IQVIA

Pasig, Metro Manila, Philippines

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience
In-depth knowledge of clinical systems, procedures, and corporate standards
Good negotiating and communication skills with ability to challenge, if applicable
Effective communication, organizational, and interpersonal skills
Ability to work independently and to effectively prioritize tasks
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards
Understanding of regulated clinical trial environment and knowledge of drug development process
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Responsibilities

Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS
Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines
Where applicable, act as a Country Lead for projects with no regional Lead assigned
Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions
Prepare site regulatory documents, reviewing for completeness and accuracy
Review, prepare and negotiate site contracts and budgets with sites, if applicable
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed
Review and provide feedback to management on site performance metrics
Review, establish and agree on project planning and project timelines
Ensure overall project efficiency and adherence to project timelines
Ensure monitoring measures are in place and implement contingency plan as needed
May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required
May assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level
May provide input into contract and budget template development
May support importation activities
May have direct contact with sponsors on specific initiatives
May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF
May act as mentor, and prepare and deliver country-specific training, for less experienced staff
May participate in feasibility and/or site identification activities
May perform Site Selection Visits if a trained monitor

Skills

Regulatory Compliance

Contract Negotiation

Budget Management

Project Management

SOP Adherence

Site Activation

Feasibility Studies

Mentoring

Training Delivery

ICF Review

Regulatory Intelligence

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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