Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. At a project and local level, may act as Site Start-up Lead (SSUL). May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs). Under the direction of the Project Manager (PM) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PM/SSUL at the project level and line manager for deliverables. At a project level, may act as SSUL for local studies. May act as the Country Start-Up Advisor (CSA).
1. Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) during start-up on allocated projects. 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.
2. Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Provides 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 legal advisor or dedicated staff responsible for data protection at the country. Provides clear data protection compliance 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 will typically 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.
3. Local Site ID and Feasibility Support - Works with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from country template. Submits proposed contract and budget for site.
4. Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution.
5. SSU Centralized Regulatory Hub Support - Performs assigned activities within the SSU Centralized Hub that support SSU activities as needed, from Site Start up to Close out, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required.
a. May serve as the primary point of contact for the SSUL/PM (or designee), during start-up or amendment management on allocated projects:
b. Provides expertise on regulatory submission requirements for post activation submissions/notifications. Responsible for the preparation of core package for amendments submissions and periodic notifications required by central and local, EC and RA, and other local regulatory authorities as needed within the country; as required by local requirements
c. Reviews essential document packages for site activation or amendment purposes, and may also be involved in essential document collection from site.
d. Support tracking of managed activities
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience. Moderate clinical research or related experience. Knowledge of and understanding of the overall drug development process. Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive. Demonstrated clinical development and clinical research knowledge. Excellent verbal, interpersonal, and written communication skills in both local and English language. Good record retention and customer service skills. Proficient in the use of computer and software systems (e.g., Excel).Ability to successfully support internal and external customers. Ability to develop, organize, and manage multiple tasks. Ability to work independently.
: Europe - DEU-Munich-Stefan-George-Ring
: Europe - DEU-Home-Based, Europe - DEU-Langenfeld-Katzbergstrasse, Europe - DEU-Neu-Isenbrg-TriforumHausC1, Europe - DEU-Berlin-Joachimsthaler-Str
: Site Operations
: Yes, 25 % of the Time
Transport/ Logistik/ Materialwirtschaft
Bereichs-/ Abteilungs-/ Gruppenleitung