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- Clinical Research Associate – Client-dedicated – Germany
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Clinical Research Associate – Client-dedicated – Germany
Pharmaceutical Product Development (PPD)
Multiple Locations
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)
Job posted: 2020-05-31