Site Start-Up & Regulatory Specialist II
Come discover what our 25,000+ employees already know : work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason we improve patients’ lives around the world.
Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
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.
Responsible for one or more of the following functions at the country level :
May serve as a point of contact for the PM / SSUL (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.
includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
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 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.
Produces site-specific contracts from country template. Provide 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 SSUL 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.