Clinical Trial Execution Manager (d/f/m)

314479BR
Jun 29, 2021
Germany

Job Description

Sandoz develops, manufactures and markets off-patent medicines, so called generics and biosimilars. In Germany, Sandoz is the leading provider of patent-free medicines with its product brands Hexal, 1 A Pharma and Sandoz. Our products offer physicians, pharmacists and patients a broad range of treatment options. They stand for competence in research and development, for good service and an economic and efficient supply - both internally and externally. Sandoz develops and produces drugs at several locations in Germany and within Europe.

For our team in Holzkirchen or Princeton we are looking for a

Clinical Trial Execution Manager (d/f/m)

Your responsibilities :

• Support the program director to ensure flawless study execution according to timelines, budget, and quality standards
• Member of the CTEM team and report to the CTEM team lead
• Provide operational coordination of Clinical Trial Team (CTT), study specific documents/plans, and key deliverables as per agreed upon timelines
• Responsible for maintaining an inspection ready TMF including follow-up with applicable functions.
• Manage trial conduct in coordination with the CTT, CRO, and any additional ESPs
• Assist in coordination of activities leading to study initiation, e.g. master informed consent template, preparation of Letter of Authorization, patient insurance, preparation and execution of contractsEnsure operational trial performance according to GCP compliance within defined timelines
• Responsible for assigned ClinOps sponsor oversight activities
• Assist program director in tracking study budget including processing invoices and accruals
• Escalate any issues for resolution of trial management operational issues within assigned program or study
• Collaborate with CTT members and ESP team to ensure successful trial execution.
• Recognize potential challenges and escalate as appropriate including developing appropriate actions.
• Ensure timely response to trial audit observations or other quality issues in conjunction with Clinical Quality Assurance (CQA)
• Assist program director in follow-up of outstanding action items

Minimum Requirements

What you’ll bring to the role:

• Bachelor’s Degree required, preferred in Life Sciences
• Minimum 5 years of experience in pharmaceutical development, preferably in clinical operations, global strategy, or clinical development.
• Excellent communication and interpersonal skills
• Profound understanding of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities
• Collaboration and Partnership: Demonstrated ability to effectively engage, collaborate and manage across functions and business units, and is the partner of choice with external partners/vendors
• People and Culture: Energizes others around purpose and impact.
• Proven ability to successfully negotiate issues, manage conflict, and escalate as required
• Fluent English (oral and written)

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make ambitious decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.

Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
SANDOZ
BioPharma SZ
Germany
Holzkirchen (near Munich)
Research & Development
Full Time
Regular
No
careers default image
314479BR

Clinical Trial Execution Manager (d/f/m)

Apply to Job Access Job Account