Clinical Research Manager Job

Date: May 15, 2019

Location: Hasharon, M, IL

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Requisition ID: CLI008758

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our Research Laboratories is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

Description

This position have a significant impact on our ability to effectively conduct clinical research and develop the pipeline, while maintaining local regulatory and compliance requirements. The role requires knowledge of how clinical trials are conducted, strong scientific understanding, talent management skills, and the ability to coordinate with key stakeholders.

Characheristics:

Support Clinical Operations and strategy management by

1. Being responsible for managing clinical research across a small country to support registration.
2. Support local and regional strategy development consistent with long-term corporate needs.
3. Serves local business needs (sign contracts, oversee and approve budgets)   
4. Responsible for studies in relevant TA's, professional support and guidance for study team, perform (delegate) Co monitoring visits with CRA.                                                         
5. Support  employee recruiting efforts by the cosource vendor 
6. Responsible for compliance with corporate policies, procedures, and quality standards.  
7. Reports adverse events internally and works with local and regional regulatory agencies to meet requirements.
8. Works with appropriate agency as appropriate to meet compliance requirements
9. Serves as regional point of contact for all internal and external stakeholders.  
10. Works internally with PV, Regulatory, and Global Medical Affairs to align on key decisions.  
11. Works with external investigators, vendors, and contractors to ensure consistency across organization.
12. Participates in knowledge generation across industry.    

Qualifications

1. MD or PhD or equivalent dgree  + 8 years of experience in clinical research, previous experience as CRM – advantage. 
2. Strong scientific and clinical background.
3. Understanding of clinical trial planning and management.
4. Extensive experience in clinical project management and coordination.
5. Expertise of core clinical, regulatory and financial systems.
6. Extensive knowledge of Israel regulatory environment  including pharmacogenetic submission environment.
7. Ability for independent decision making and ability to operate with minimum oversight and supervision.
8. Strong communication and leadership skills.
9. Good problem solving skills - Early identification of problems and/or conflict, with appropriate analysis and mitigation plans. 
10. Ttraining and mentoring skills.
11. The ability to focus on multiple deliverables and protocols simultaneously is essential.
12. Ability to work effectively also in a remote virtual environment with a wide range of people.
13. Strong coordination and organizational skills.
14. Fluency in both English and Hebrew.

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life. 



Job: Clinical Research Monitor
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Clinic, Medical, Medical Research, Clinical Research, Healthcare, Research

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