Clinical Operation Manager
vor 2 Monaten
**Job Description**:
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
We are continually striving to improve the understanding of health care within the local community. Our site in 1100 Vienna (ICON Tower) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site. As an addition to our Global Clinical Trial Operations Team based in Vienna, we are looking for a Clinical Operations Manager (COM) (permanent full-time contract).
**Clinical Operation Manager (M/F/d)**
As a Clinical Operations Manager, you are responsible and accountable for assigned protocols for budget/finance aspects, for execution and oversight of clinical trial submission and approvals in Austria and to ensure site ready.
**The primary activities include but are not limited to**:
- Executes and oversees clinical trial submissions according to EU CTR and approvals for assigned protocols.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements.
- Oversees clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs.
- Coordinates and liaises with Clinical Research Managers, Clinical Trial Coordinators, CRAs to ensure country deliverables are obtained for submissions, budgets, contracts and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
**Qualifications**:
- Bachelor’s Degree in Life Science, Biology or equivalent. Education in business finance or administration would be advantageous
- Minimum of 3-5 years’ experience in clinical research or clinical research + finance
- Deep knowledge of the Austrian/European regulatory environment, as well as scientific and clinical research knowledge is required.
- Excellent German and English communication skills (verbal and written). Strong communication, leadership, and negotiation as well as excellent influencing and mentoring skills
- Knowledge in budget and contract negotiation, submission and approval process.
- Strong coordination and organizational skills.
- Ability to make decisions independently with limited oversight from the manger. Proactively develop risk management and mitigations plans and resolve issues locally
- Effective and efficient time management, organizational and interpersonal skills
- High sense of accountability and urgency in order to properly prioritize deliverables, ability to focus on multiple deliverables and protocols simultaneously is essential
- Ability to work effectively in office but also remote/virtual environment with a wide range of people
- Positive mindset, growth mindset, being self-driven
**Who we are...**
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
**What we look for...**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here,
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