Job Responsibilities
* Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in the agreed upon SSU tracking system in real time; if forecasted timelines are not reached, investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
* 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 Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
* Supports continuous improvement of quality in all Site Start‐Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
* Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
* Responsible for the Local Submissions Specialist - follows the project direction provided by the designated country start‐up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start‐up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
* May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end-to-end process at country/site level.
* Country Start‐Up Advisor – acts as Subject Matter Advisor for in‐country performance within the Site Start‐Up. Supports country‐level intelligence on start‐up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of a legal advisor or dedicated subject matter, may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start‐up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level. Local Site ID and Feasibility Support – provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
* May be asked to perform: Local Investigator Contract and Budget Negotiator – provides support to SAM to agree on country template contract and budget. Produces site‐specific contracts from country template. Provides support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Qualifications
* Bachelor's Degree.
* Detailed understanding of clinical trial process across Phases II‐IV and ICH GCP.
* Ability to understand clinical protocols and associated study specifications.
* Detailed understanding of clinical trial start‐up processes.
* Ability to manage external vendors to contract effectively.
* Strong organizational skills with ability to handle multiple tasks effectively.
* Strong written and verbal communication and interpersonal skills.
* Ability to manage multiple project budgets with increased complexity and value.
* Quality‐driven in all managed activities.
* Good problem‐solving skills.
* Good negotiating skills.
* Demonstrated ability to work independently as well as part of a team.
Equal Opportunity Statement
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Further, the Company is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of your application process, please contact us at for alternate means to submit your application.
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