FSP Top Global Pharma
*Support the site contract team to maintain tracker & system & database, other clinical admin support
*Fluent in English
JOB SUMMARY
- Responsible for providing assistance in the delivery of Site Start-Up (SSU) activities in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and essential documents required for site initiation.
- Support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager and Central and Shared Services leadership.
- Ensures regulatory and site contract documentation complies with sponsor and Company requirements.
- Works with internal and external team members to implement solutions for project and/or individual site contract related problems.
- Establishes strong working relationships with customers, internal project teams and sites.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company Standard Operating Procedure (SOP)/Sponsor requirements.
JOB RESPONSIBILITIES
- Provide support with site selection lead and Project Manager (PM)/SSU Leadership (SSUL) to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Assists in administration of contract management and essential document processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project, country and site level.
- Assists with quality control processes and translation processes related to submissions, contracts and essential documents.
- Under supervision may assist in negotiations of budget and contracts with site and via Site Contracts Service Center and SSUL with Sponsor until resolution of issues.
- Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
- Assists SSU staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
- May serve as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
- Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
- Arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- Provides support in preparation of Ethics Committee, Regulatory and any other relevant local applications and submissions.
- May assist in ensuring compliance within the forecasted country/site timelines, helping to ensure compliance with milestone progress in agreed upon SSU tracking system in real time.
- Facilitates the execution of contracts by company signatories.
- Supports the maintenance of contract and essential document templates and site-specific files and databases.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with SOPs and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
QUALIFICATION REQUIREMENTS
- Bachelor Degree or equivalent combination of education and training preferred.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to interact effectively and appropriately with investigative site personnel and internal stakeholders.
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Ability to effectively communicate across multiple function groups (Clinical team, PM, Director).
- Demonstrated ability to work independently, as well as part of a team.
- Utilize problem-solving techniques effectively.
- Quality-driven in all managed activities.
- Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
- Strong computer skills, including Word, Excel, PowerPoint, Publisher.
- Business level of proficiency in written and spoken English language.