**Qualifications**:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
K**nowledge, Skills and Abilities**:
- Ability to work in a team or independently as required.
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
- Strong customer focus.
- Flexibility to reprioritize workload to meet changing project timelines.
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout.
- Good English language and grammar skills and proficient local language skills as needed.
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
- Ability to successfully complete the organizations clinical training program.
- Self-motivated, positive attitude and good interpersonal skills.
- Effective oral and written communication skills.
- Good interpersonal skills.
- Essential judgment and decision-making skills.
- Capable of accurately following project work instructions.
- Good negotiation skills.
- Independent thinker.
- Ability to manage risk and perform risk escalation appropriately.
**Essential Functions**:
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads.
- Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Where applicable, conducts on-site feasibility visits (Asia Pac only).
- May support scheduling of client and/or internal meetings.
- May review and track of local regulatory documents.
- May provide system support (i.e., Activate & eTMF). May support RBM activities.
- May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
- Transmits documents to client and centralized IRB/IEC.
- Maintains vendor trackers.
- Supports start-up team in Regulatory submissions.
- Works directly with sites to obtain documents related to site selection.
- Assists the project team with the preparation of regulatory compliance review packages.
- Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
- May complete the 'Site Interest Plan' in CTMS and collection and delivery of associated documents from investigators and site personnel.
- Documents in real time all communication, attempts a follow up associated with site contact and survey responses.
- Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
- Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
- Ensures an efficient, effective plan is in place for site contact and follow up.
- Ensure compliance with the pla