Gouya-Insights is a strategic clinical innovation experts company in the biotechnology and pharmaceutical industry. We have set ourselves the goal to impact significantly the drug and medical product development landscape. Our highly motivated team is committed to shape the dynamic clinical drug and device development process.

Currently we are looking for a

Clinical program manager for clinical trials

In this position, you are responsible for developing the strategy, organization and logistics of clinical drug or device development. The clinical program manager develops, manages and reports on, and is accountable for the activities of the clinical programs and is the first point of contact between all participants of the internal and external clinical team, such as the sponsor, the principal investigator (clinical trial leader), and all third party vendors.

Your qualification as clinical program manager (m / f) for clinical trials are:

·       Advanced degree in Life Sciences, Medical or Pharmaceutical studies or equivalent education

·       Experience in clinical program management, clinical development strategy and study design/trial management

·       Proven track record in leading multi-functional teams and ability to be an effective leader

·       Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise

·       Proven ability to interpret complex clinical data

·       Demonstrated excellence in stakeholder management

·       This role requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change

·       Excellent verbal and written English and German communication skills are a must

·       Demonstrated skills in networking internally and externally and communicating in situations requiring special tact and diplomacy

·       Possesses sound operational knowledge of the pharmaceutical industry and broader R&D processes including scientific activity impacting project work

·       Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research

·       Demonstrates a proven ability to both independently complete and lead peers in completion in components of complex plans, i.e. draft protocols, selecting appropriate methodologies, measures, analytical plans and evaluation tools

Key Accountabilities: 

·       Lead the delivery of clinical development activities for a clinical stage program and acts as major contributor to integrated clinical development strategy and clinical development plans

·       Contribute to the medicine development strategy 

·       Responsible for oversight of development and execution of studies linked to worldwide clinical development plans for assigned programs

·       Ensures clinical, operational and medical governance excellence across all clinical development projects for assigned programs

·       Assures clinical studies are conducted effectively in partnership with third vendors, alliance partners and clinical operations colleagues and CRO as appropriate

·       Functional lead of clinical study teams in development and conduct of clinical studies

·       Lead authoring of study documents, CRF's and contribute to development of analytical plans

·       Reviews standard format data displays in protocols and CRF's to assure consistency in data capture

·       Accountable for authoring of clinical study reports and Investigator Brochures

·       Assist in producing materials for Investigator meetings

·       Participate in data review discussions and contribute to data interpretation

·       Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission documents

·       Assist with the writing of manuscripts and development of abstracts and presentation materials

·       This role also contributes to individual studies and project level activities, as appropriate.  This includes responsibility and accountability for the coordination, execution and delivery of one or more studies and programs

You are interested?

We are looking forward to receiving your complete application documents - preferably by e-mail - to:

Priv.Doz. Dr. med Ghazaleh Gouya Lechner: gouya@gouya-insights.com

Gouya Insights KG, Elisabethstrasse 22/12 A-1010 Vienna / AUSTRIA