Senior Clinical Project Manager (m/f/d) - Sponsor Monitoring & Site Oversight

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

With over 1700 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.

This is a sponsor-side Clinical Operations role with a strong focus on oversight of monitoring activities, CRA performance and investigational sites across global clinical trials. We are particularly interested in candidates with hands-on monitoring experience, for example as a CRA, Lead CRA or Clinical Trial Manager, who are ready to take on sponsor oversight responsibilities.

Your main tasks and responsibilites

• Oversee monitoring activities and CRA performance, including report review, co-monitoring, issue follow-up and escalation
• Support site selection and oversee site activation, recruitment, compliance, performance, risks and issue resolution
• Ensure (e)TMF quality, completeness and timeliness and support inspection and archiving readiness
• Oversee central laboratory setup, sample logistics, data flow, reconciliation and lab-related issues
• Support vendor selection and oversee delegated activities, performance, risks and escalations
• Develop and review study-specific plans, templates and training materials and oversee completion of required study training
• Identify and escalate operational and quality risks
• Support issue management, CAPAs, audits and process improvements
• Act as SME for assigned areas and contribute to onboarding, training, departmental initiatives and implementation of new systems/processes

Your expertise and ideal skill set

• Medical-pharmaceutical or scientific university degree
• At least 5 years experience in clinical research and monitoring oversight
• Previous experience as a Clinical Research Associate, Clinical Trial Manager or Clinical Project Manager
• Knowledge of the pharmaceutical industry or CRO industry and of the global clinical trials environment
• Previous monitoring / co-monitoring experience, preferably across different countries
• Solid experience with Phase 2 or 3 studies and good IT skills
• Proficient in English (written and oral), additional languages beneficial
• Strong interpersonal communication and organizational skills
• Ability to work efficiently in a team environment and work to tight deadlines

Your department - where you make an impact

• We, the Clinical Research & Development department, conduct clinical research to develop new products and ensure their safe and effective use throughout their overall life-cycle. Our ultimate focus in our daily work is on increasing patient health and safety.

Thrive with us

• Company restaurant & meal subsidy
• Training & further education
• Health promotion
• Parking spaces and good public transport connections
• Company and team events

Enjoy these attractive benefits! You can find all offers here: Benefits

The minimum gross salary according to the collective agreement (chemical industry) is EUR 4.355,55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

Do you have any questions? Then get in touch with your contact person.

Johanna Proksch, MA

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Wien

T: +43 (1) 610 32 - 4299

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.