Sr site start-up & regulatory specialist (remote) south africa

Sr Site Start-Up & Regulatory Specialist (Remote) South Africa

Updated: Today

Location: Bloemfontein, EC, South Africa

Job ID: Job Responsibilities General – Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Country Manager. Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified. Monitors 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 WI in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements. Ensures continuous improvement of quality in all Site Start-Up components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).

May be involved in vendor management.

Responsible for one or more of the following functions at the country level: Local Submissions Specialist – Follows the project direction and expertise provided by the designated country start‑up advisor (CSA) and PM/SAM. May serve as the primary point of contact for the PM/SAM (or designee) during start‑up on allocated projects. Compiles 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.

Oversees 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 minimal 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 Expert for in‑country performance within the Site Start‑Up. Acts as country‑level intelligence on start‑up (SU) and clinical trial regulatory (CTR) activities.

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.

Local Site ID and Feasibility Support – Provides support 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.

Local Investigator Contract and Budget Negotiator – Produces site‑specific contracts from country clinical trial agreement template. Reviews and owns site‑specific contracts from country template. Submits proposed CTA and investigator budget for site review.

Negotiates budget and contract with site and via Site Contracts Service Centre and SAM with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Line management / mentoring responsibilities – As part of developmental plans, it may be requested to provide support to management in activities such as interviewing and selection, professional development, performance management, and employee counseling and separations. Advises junior team members on administrative policies and procedures, technical problems, priorities and methods.

May act as Country Delivery Lead – Responsible for operational delivery across the county portfolio for country participation through to site start‑up and ending in site activation and First Patient In. Analyses country and site metrics to ensure baseline project deliverables are being met to facilitate first patient in Sponsor projections; including planned baseline for completed regulatory green light with fully executed site contracts and increase efficiency in overall project delivery. Performs operational site level planning, including efficient allocation of resources within country.

Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.