Trial Activation Contract Specialist I FSP
Thermo Fisher ScientificSalary not specified
Full Time
Junior (1 to 2 years)
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Site Activation Specialist position?
This information is not specified in the job description.
Is the Site Activation Specialist role remote or office-based?
This information is not specified in the job description.
What are the key requirements for the Site Activation Specialist role?
Candidates need a Bachelor’s Degree in life sciences or related field with 3 years’ clinical research experience, in-depth knowledge of clinical systems and procedures, good negotiating and communication skills, and knowledge of GCP/ICH and applicable regulations.
What does the work environment look like at IQVIA for this role?
This information is not specified in the job description.
What makes a strong candidate for the Site Activation Specialist position?
Strong candidates have a Bachelor’s in life sciences with 3+ years in clinical research, in-depth knowledge of clinical procedures and regulations, effective communication and negotiation skills, and the ability to work independently while building relationships.
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