Medical Monitor for non-interventional studies (f/m/x)

Are you looking for more than just a job - would you like to find a

place where your skills are not only in demand, but also valued?

Welcome to DEKRA Arbeit. Become part of our team as Medical Monitor

for non-interventional studies (f/m/x) at our client in Munich in

full-time.

your Tasks:

• Act as Medical Monitor by assisting project managers in identifying

the key risks to data that are critical to the primary objective, and

providing medical input into risk mitigation strategies

• Developing/updating the Medical Monitoring Plans

• Supporting study teams, investigators and sites with medical

expertise

• Medical input into adverse event handling, including review of

cumulative ADR/SAE listings and any other emergent safety information

• Reviewing clinical data and the critical parameters of studies

• Assisting the Senior Project Leader with day-to-day logistics of

assigned study related tasks. The main activities include

administrative tasks in the field of study coordination.

• Support in trial team activities such as trial documentation

management, milestone tracking and identification, resolution and

escalation of issues.

• May participate in regular study meetings, organize meetings and

coordinating internal and extermal communication. May prepare meeting

agendas and minutes

• Support the Senior Project Leader in supervision of CROs and other

3rd party vendors

• Management of the Trial Master File and conducting the Sponsor

Quality Control of uploaded documents and update of trial related

systems (CTMS)

• Close collaboration with Medical Affairs, DS Affiliates, and all

other functional departments at DS.

• Support of Affiliates during site selection process

• Cooperate with the Senior Project Leader in budget control and

forecasting.

• Study related interactions with HCPs in Steering Committees, Data

Safety Boards and Investigator Meetings

your Profile:

• You hold a graduate degree medical doctor (MD) or pharmacist with

at least 6 years relevant clinical and scientific experience

• Strong experience Cardiovascular is required. Helpful if Oncology

experience is available

• You have a strong understanding of regulatory environment (thorough

knowledge of Clinical Research Principles, ICH –GCP , EU regulations

governing clinical trials, standard regulatory and clinical practices

and current regulatory issues related to clinical research; familiar

with local regulations for non-interventional studies within EU)

• Knowledge of pharmaceutical business and international drug

development

• Pro-active and self-motivated personality

• Excellent presentation & communication skills - combined  with a

strong stakeholder focus

• Fluent written and spoken English knowledge

What we offer you:

• A permanent employment contract in accordance with the BAP

collective labour agreement

• A salary above the collective agreement, plus holiday and Christmas

bonuses

• An interesting job that matches your qualifications with the

prospect of being taken on by the client company

Your way to us:

If you would like to apply directly, you are welcome to send us your

CV by e-mail or send us your details via the online application. When

applying online, you can ‘upload’ your CV after entering your

contact details. We encourage diversity and welcome all applications.

As part of DEKRA SE, DEKRA Arbeit GmbH is one of the top 6 personnel

service providers in Germany and one of the fastest growing personnel

service providers in Europe.

At currently more than 120 locations throughout Germany and Europe, we

have made it our business to establish flexible personnel solutions

and thus positively shape the regional labor market. Help us to

further expand this successful model and apply today.