Established in 1982, Chiltern is a leading global clinical Contract Research Organization (CRO) offering specialized services in oncology and a range of other therapeutic areas, together with global sourcing and FSP solutions. Chiltern's 4,200 employees work in more than 47 countries, offer expertise, engagement, and tailored, responsive solutions to meet the demands of biotech and pharmaceutical partners of all sizes.
Chiltern Source is a leading business unit within Chiltern offering a fully integrated solution to all contract clinical research staffing and internal hiring needs. With over 30 years' experience in providing clinical professionals to Pharmaceutical, Biotechnology, Device, and Diagnostic companies, as well as National Health Authorities (e.g. NHS), we are a market leader who is known for providing quality clinical research professionals and service excellence.
For our client, an international pharmaceutical company located in the Rhein-Main region near Frankfurt, we are seeking a Study Start Up Specialist (m/f) with focus on either Submissions or Contract Management located office based at the client.
Site Activation Associate (m/f) - Ref. 898992 The European Site Activation Associate (EU SA Associate) is accountable for site activation for the country sites, in alignment with the priorities of the Business Units. In carrying out this responsibility, the EU SA Associate will be responsible for obtaining clinical trial authorisations, ethical approvals (including maintenance activities), execution of contracts (including budgets), and ensure that the sites are timely declared Enrolment Ready (ER).
The key responsibilities of this mission will be: • Regulatory delivery • Drive site set up towards enrolment readiness by collaborating with the Clinical Research Associate (CRA) and other stakeholders within the company • Clinical Operations single point of contact for National/Independent/Site´s ERB and, where applicable,Competent Authority (CA) from start up to closure of clinical studies • Provide historical site activation data to Clinical Operations teams to enhance site selection discussions ensuring the appropriate sites are participating in the study • Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes (Germany and Switzerland) • Coordinate translation process for all required trial documents and oversee the quality of final documents • Prepare the initial country/site study-level ICFs (Informed Consent Form), as well as revisions as a result of protocol amendments, risk profile updates, etc. • Contribute to the country specific ICF template review • Drive collection of required regulatory documents for investigative sites and network with external parties as needed • Drive timelines for both ERB/CA submissions and approvals, of country-level regulatory package • Develop and maintain relationships with ERB/CA, where applicable • Identify potential issues and anticipate current trends related to regulatory/ethical issues and create plan to mitigate them • Ensure that required documents for importation/exportation of IP and non-IP are obtained as needed • Maintain active relationships and/or memberships with applicable research organizations, if applicable • Communicate site-level activation progress to appropriate study team members • Build strong partnership with relevant internal functions (e.g. Clinical Trial Data Management, Clinical Trial Management) • Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times • Prepare submission files • Support review and approve Regulatory Template and Multi-phrase translation packets for label creation, where applicable • Assist Clinical Operations Manager and other stakeholders as required to run relevant reports • Participate in regional meetings and share best practices • Ensure compliance to the country regulatory requirements withininternal systems and maintain it up to date
• Bachelor's degree, preferably in a scientific/health field, or appropriate demonstrable relevant experience in a similar role • At least 2 years Clinical Research experience • Strong knowledge of regulations, legislations and guidelines applicable for the conduct of clinical studies • Clinical language knowledge and broad Therapeutic Area knowledge including understanding medical language • Ability to work according to strict deadlines, prioritise and manage multiple customers • Strong interpersonal skills • Demonstrated decision-making ability and strong negotiation and arbitrations skills • Strong organisational, analytical and problem-solving skills • Excellent teamwork/interpersonal skills and excellent customer relationship skills • Demonstrated ability to operate and influence across functions and business areas • Excellent written and verbal communication, and presentation skills • Fluency in both verbal and written German and English • ICH Good Clinical Practice knowledge • Experience with good documentation practices • Excellent computer skills with experience in variety of software packages
Your contact: Mrs. Christina Börner, Resourcing Manager, is pleased to answer your questions in regards to this vacancy, telephone number (0)-255.
Your application: We are looking forward to receive your detailed application, ideally by email, indicating the reference number 898992:
Chiltern International GmbH Christina Börner Resourcing Manager Norsk-Data-Strasse 1 61352 Bad Homburg Germany dl: f: t: 0