Unblinded Clinical Trial Manager

vor 5 Monaten

Wien, Österreich Octapharma Vollzeit

Job ID: 57436- Location: Wien, AT- Job Level: Professionals- Job Category: Research and Development- Employment Type: Permanent position- Career Level:
Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team.

**Your new challenges which will inspire you**:

- Working close with unblinded sites staff to ensure oversight of unblinded site activities
- Supervise unblinded monitoring activities (visits frequencies, trip report reviews and follow ups)
- Conduct co-monitoring visits (on site or remote), to verify the quality of unblinded monitoring visit performance and be the first point of contact for CRO uCMPL and uCRAs
- Oversight of CRO uCRA trainings to ensure proper training of study-specific processes
- Review of CRO’s unblinded eTMF maintenance or direct filing of documentation provided by uCRAs to ensure timely and accurate submission of study documents according to the plan
- Supply blinding materials to ensure sufficient adequate equipment
- Develop, write and review study-specific documents and manuals (including final clinical study reports)
- Identify any areas of concern and risks within assigned clinical trials and report them to Global CPM
- Provide input and review SOPs, Working Instructions and guidelines as well as support internal audits

**Your profile that will convince us**:

- University Degree in natural sciences or clinical sciences
- Several years of professional experience in clinical trial management and/or clinical research
- Experience within the pharmaceutical industry or in a CRO (Contract Research Organization)
- Hands-on experience in managing and mentoring teams
- Independent, communicative, proactive, goal-oriented, and reliable work approach
- Fluent English, German is advantageous Willingness to travel internationally**Our attractive benefits for you**:

- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market. Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
**Additional information**:
The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.

**Your contact**:
Marina Ibrahim, M.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 - 1308

**About Octapharma**:
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs nearly 12,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 195 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care.

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