Clinical Research Associate – Client-dedicated – Germany

Submission for the position: Clinical Research Associate – Client-dedicated – Germany - (Job Number: 170560)Clinical Research Associate – Client-dedicated – Germany

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our team is expanding, and we expect to have a new opportunity for a CRA to be dedicated to one client only, using and working with their systems, SOPs and monitoring only client’s studies.

Responsibilities include but are not limited to:

• Monitoring independently different sites, including RBM.

• Participation in investigator meeting as necessary

• Ensuring the trial is conducted in accordance with the approved protocol ICH-GCP guidelines, SOPs etc

• Ensuring effective communication between investigational sites and internal/external stakeholders

• Working on project work and initiatives for process improvement as required

Clinical Research Associate – Client-dedicated – Germany

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our team is expanding, and we expect to have a new opportunity for a CRA to be dedicated to one client only, using and working with their systems, SOPs and monitoring only client’s studies.

Responsibilities include but are not limited to:

• Monitoring independently different sites, including RBM.

• Participation in investigator meeting as necessary

• Ensuring the trial is conducted in accordance with the approved protocol ICH-GCP guidelines, SOPs etc

• Ensuring effective communication between investigational sites and internal/external stakeholders

• Working on project work and initiatives for process improvement as required

Requirements

Education and Experience:

• Degree in pharmacy, life science or related field

• Experience in a pharmaceutical, biotech or CRO company

• Independent clinical monitoring experience

• Fluency in English and German

Knowledge, Skills and Abilities:

• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

• Excellent understanding and demonstrated application of GCPs and applicable SOPs

• Management of regulatory and / or IEC questions

• Development and preparation of the local informed consent form

• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

• Management of the delivery of study supplies

• Strong customer focus

• Effective interpersonal skills

• Strong attention to detail

• Effective organizational and time management skills

• Proven flexibility and adaptability

• Ability to work in a team or independently as required

• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software

“Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.”

*LI-SH1

Requirements

Education and Experience:

• Degree in pharmacy, life science or related field

• Experience in a pharmaceutical, biotech or CRO company

• Independent clinical monitoring experience

• Fluency in English and German

Knowledge, Skills and Abilities:

• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

• Excellent understanding and demonstrated application of GCPs and applicable SOPs

• Management of regulatory and / or IEC questions

• Development and preparation of the local informed consent form

• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

• Management of the delivery of study supplies

• Strong customer focus

• Effective interpersonal skills

• Strong attention to detail

• Effective organizational and time management skills

• Proven flexibility and adaptability

• Ability to work in a team or independently as required

• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software

“Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt.”

*LI-SH1

Submission for the position: Clinical Research Associate – Client-dedicated – Germany - (Job Number: 170560)