IQVIA Healthcare Jobs in Accra
1. Patiently scroll down and read the job description below.
2. Scroll down and find how to apply or mode of application for this job after the job description.
3. Carefully follow the instructions on how to apply.
4. Always apply for a job by attaching CV with a Cover Letter / Application Letter.
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities following applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
- Inform team members of the completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and the project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
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Qualifications
- Bachelor’s Degree 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.
- 3 years clinical research experience, including 1-year experience in a leadership capacity.
- Equivalent combination of education, training, and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with the ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, including local regulations, SOPs, and the 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.
1. Patiently scroll down and read the job description below.
2. Scroll down and find how to apply or mode of application for this job after the job description.
3. Carefully follow the instructions on how to apply.
4. Always apply for a job by attaching CV with a Cover Letter / Application Letter.
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities following applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
- Inform team members of the completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and the project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
ADVERTISEMENT - CONTINUE READING BELOW
Qualifications
- Bachelor’s Degree 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.
- 3 years clinical research experience, including 1-year experience in a leadership capacity.
- Equivalent combination of education, training, and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with the ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, including local regulations, SOPs, and the 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.