Senior Clinical Research Scientist - Frankfurt Am Main, Deutschland - BI Pharma GmbH&Co

BI Pharma GmbH&Co

Geprüftes Unternehmen

Frankfurt Am Main, Deutschland

vor 1 Woche

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

The Position:

Join us as Senior Clinical Research Scientist and maximize the value of our fully outsourced trials in the Boehringer Ingelheim pipeline.

You will be working in an open-minded team which allows you to create and contribute to structures and establish new processes.

In this role you will act as the Clinical Trial Leader with full responsibility for planning, conducting and reporting of multinational projects/trials (phase I-III) which are outsourced to CROs or academic partners.

You assume technical leadership of an international trial team composed both of internal and external trial team members as well as responsibility for the overall study budget.

Tasks & responsibilities:

You take responsibility for trial preparation; you will define the scope to develop the request for proposal to the CRO/academic partner and review and negotiate the proposals and change orders as applicable (in collaboration with the Outsourcing Manager).
Make sure you keep the full trial oversight, including continuous monitoring of safety of the study participants and the benefitrisk ratio of trial participation as well as adherence to respective regulations and guidelines.
You monitor and supervise progress of the projects/trials (including identifying risks and bottlenecks), and report issues and progress to the internal stakeholders and committees.
As networker you liaise with key clinical investigators/opinion leaders/external consultants/advisory board members/regulatory agencies.
Moreover, you support internal colleagues from R&D and other involved functions in preparing relevant documentation for submission to regulatory agencies.
Finally, you ensure regular exchanges with the whole internal and external trial teams in particular the CRO and team members of other 3rd party vendors.

Requirements:

Doctoral or master ́s degree with major focus in medicine, natural sciences, pharmacy or equivalent areas
Track record of at least several years managing successfully all operational aspects of clinical drug development including CRO collaborations
Extensive experience and proven track record of clinical trial project management and CRO interface management
Relevant experience has been gained in the pharmaceutical, biotech or medical device industry and on a global level
Excellent communication and interpersonal skills to work effectively as an interface between internal and external partners
Experience in large outcome trials would be a plus

Ready to contact us?:

If you have any questions about the job posting or process - please contact our HR Direct Team,

Recruitment process:

Step 2:
Virtual meeting starting in January

Step 3:
On-site interviews beginning mid January