An opportunity has opened for a SCRA/ Vendor Oversight Lead to join a medium sized, successful Pharmaceutical company based in Switzerland who have over 2,000 employees based globally. This opportunity would suit a SCRA from a Pharma, Biotech or CRO who is looking to take that next step working with vendors/ CROs whilst being hands on with the studies still so you'll have the chance to work in a dynamic position.
My client is open to relocators outside of Switzerland where they can support your relocation which will give you the chance to grow your career in Switzerland. You'll be required to travel to different sites across the EU so speaking fluent English is essential for this opportunity but speaking another language is preferred too.
Being an established company, you'll have the support and training facilities to grow at the organisation long term in the future so this position will suit a 'career minded' individual who wants to progress in their career.
What's on offer? A flexible basic salary between 110k-125k CHF per annum, Bonus, Relocation assistance, healthcare + much more.
Responsibilities:
- Participate in CRO and vendor selection process.
- Provide project-specific support for external study team (personnel at CRO and other clinical study vendors), ensure proper adherence to clinical research regulations.
- Participate in development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, Project Management, etc.), and other study-related documents (manuals, instructions, etc.).
- Assist in development of Case Report Forms (CRFs).
- Manage creation of study-related templates and logs by CRO.
- Manage investigative site selection process for clinical trials.
- Manage external vendors that provide systems supporting clinical trial conduct (e.g., CTMS, EDC, IWRS, eTMF, etc.).
- Track status of clinical trial deliverables.
- Support site recruitment, and patient recruitment.
- Coordinate and participate in Investigators' Meetings.
- Train CRO CRAs on internal company processes.
- Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim monitoring visits, and close-out visits).
- Review and follow-up on monitoring visit reports ensuring adherence to GCP/ICH.
- Manage investigational product accountability and reconciliation process.
- Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies.
- Assist in query resolution and data listings review process prior to the database lock.
- Coordinate the collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files.
- Prioritize, adapt to and execute business plans or goals.
- Interpersonal skills to interact and collaborate with others appropriately and effectively.
- Presentation skills (oral and/or written) that inform, inspire, and persuade.
- Plan, organize, and manage resources to bring about the successful completion of projects.
- Build collaborative relationships with internal and external customers.
- Possess critical thinking and creative problem-solving skills.
- Influence and manage relationships and/or alliances.
- Consistently demonstrate behavior compliant with regulatory, legal, and corporate requirements and in accordance with the cultural values.
- Successfully navigate and work within a fast-paced, changing environment.
- Successfully navigate and work within a complex, regulated and matrixed environment.
- Effectively and appropriately leverage tools and resources to grow the business.
- Excellent leadership and teamwork skills.
- Able to plan proactively, manage multiple priorities and deliver against tight deadlines.
Minimum Requirements:
- Bachelor's or higher degree in science, nursing, or equivalent with 4+ years of experience in biotech, pharmaceutical, or CRO industry.
- Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials .
- Experience in site monitoring and oversight of contract service providers.
- Familiarity with pharmaceutical and medical terminology.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Publisher.
- Experience with different EDC and IWRS platforms.
- Travel required (~10%).
If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 (0) 203 846 0646.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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