initiation Clinical Site Manager II
- Employer
- Parexel
- Location
- Berlin, Germany
- Salary
- Competitive
- Start date
- 17 Oct 2019
- Closing date
- 23 Oct 2019
View more
- Discipline
- Clinical Research
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
The iCSM acts as PAREXEL's direct point of contact with assigned sites, and is accountable for quality and delivery during the start-up phase.
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
of country/regulatory/client requirements), and customize and negotiate any amendments.
receipt of final approval.
- IRB/IEC and MoH / RA submission/approval,
- Site activation
- Patient recruitment & retention.
not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in
training, data quality or integrity, study non-compliance, etc.
training requirements prior to study start.
Qualifications
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
- Able to work independently
- Client focused approach to work
- Ability to interact professionally within a client organization with the support of manager or CSMⅡ/Ⅲ
- Flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Sound interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables,
- Developing ability for effective time management in order to meet study needs, team objectives, and department goals
- Developing ability to work across cultures
- Shows commitment to and performs consistently high quality work
- Ability to successfully work in a ('virtual') team environment
Company
Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB
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