[Hiring] Senior Site Activation Specialist @Syneos Health

Role Description

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 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.

• 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 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.
• 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 negotiating skills.
• Good problem-solving skills.
• Demonstrated ability to work independently as well as part of a team.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Company Description

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.