Global Regulatory CTA Operations Lead
- Lead a dedicated CTA Operations team to ensure timely clinical trial approvals globally in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
- Ensure management and oversight of the CROs performing CTAs to ensure quality, timely approvals, and compliance.
- Be a Subject Matter Expert for CTA related topics and ensure continuous process improvement.
- Responsible for the generation, maintenance and provision of metrics on workload as well as KPIs for key CTA activities and analyze consolidated data.
- Support budget development and forecast management related to CTA activities.
- Maximize the use of human and fiscal resources through effective planning. Calculate manpower and cost projections.
- Assess the activity/performance of team members and/or subordinates by establishing objectives, and conducting performance appraisals for team members.
- Will act as a Global Regulatory Study Lead (Lead CTA activities for all Clinical Trials during the entire study lifecycle; Perform CTA submissions in selected countries; Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders, etc.).
- Establish and maintain excellent communication and working relationships with Clinical Development Operations to ensure timely clinical trial approvals globally and with GCSP for the management of regular safety reporting to Health Authorities, during the clinical development phase of CSL Behring products.
- BSc/MSc degree or equivalent in life science, pharmacy, medical laboratory technology, or other health/medical related area. (Other degrees and certifications considered if commensurate with related quality management, regulatory or clinical research experience.)
- As a guide, a minimum of 8+ years’ experience in managing Clinical Trial Authorizations.
- Experience in leading and managing a global team of professional staff.
- Excellent written and oral communication skills in English – German is a plus.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
Not yet ready to apply? Sign up to be notified of future opportunities
Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
We source and screen thousands of candidates and applications per year and recommend the most qualified candidates to our clients.
If you want to apply for one of the open positions with one of our clients you can do this through this website. Please enter the required data and upload your CV. Our recruitment consultants will screen your application very thoroughly. You will receive via email constant updates on the status of your application. Please apply for each position you are interested in.