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Global Study Associate Managers (GSAM) - global Pharma - Office-based in Warsaw, Poland

Company: SRG Clinical
Location: Warsaw, Poland
Reference: perm-GSAM-Warsaw2018-Arnaud@SRG
Closing Date: 10 Aug 18
Type: Permanent
Salary (£): Negotiable
Benefits: Permanent position, Generous Salary, One of the fastest growing clinical group worldwide

Job Summary:

A Global Pharma has entrusted me to find Global Study Associate Managers (GSAM) to add to their booming clinical unit in Warsaw, Poland.

Requirements:

Clinical Development Associate Managers / Global Study Associate Managers (GSAM) - global Pharma - Office-based in Warsaw, Poland

Permanent position

Generous Salary

No Local (Polish) language requirement

One of the fastest growing Clinical Cluster worldwide

Working together on an ambitious project, I am assisting a key strategic partner in their search for numerous Clinical Development Study Managers or Global Study Associate Managers (GSAM) to add to their fast growing headcount in Poland. This is a rare opportunity to work on global projects for one of the most highly regarded brand in the industry! As mentioned above, the company operations are growing very fast in the region so applicants from outside Warsaw or Poland are welcome to apply, even without polish speaking skills.

The successful Study Operation Specialists will lead and manage clinical delivery teams, liaise with cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas. The ideal candidate will show a good understanding of clinical data flow as well as excellent verbal and written communication skills.

Responsibilities (not limited to):

  • Coordinate operational aspects of the organization and Investigator Sponsored studies from Study Start, Proposal through CSR and Publication.
  • Lead activities that ensure quality, consistency and integration of study data 
  • Interface with Data Management Department, to facilitate the delivery of study data
  • Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables
  • Implement globally agreed Operations and Clinical Development strategies (including processes and use of technical systems related to Operations)
  • Contribute to protocol development and the development of other Operations documents
  • Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
  • Contribute to review of project Clinical Information Standards (CIS) Standards Repository Components
  • Lead the preparation of study documents ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc.)
  • Ensure timely entry of appropriate information into the firm tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)
  • Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers
  • Support the study delivery team in the development of and implementation of audits and regulatory inspections
  • Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
  • Monitor study conduct and progress, proactively identifying to and resolving with the Clinical Development Manager, issues which may impact delivery of the study
  • Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary
  • Contribute to ad hoc team productivity and efficiency by providing direction and facilitating good team dynamics
  • Provide input into non-drug project work including training activities, and development of procedures 

Requirements:

  • Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
  • Experience working on clinical studies, across different phases of drug development
  • Relevant industry experience
  • Proven organizational and analytical skills
  • Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
  • Computer proficiency
  • Excellent knowledge of spoken and written English

About SRG:

SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of ‘Creating Tomorrow’s World’& helping patients world-wide.

HOW TO APPLY?

For an immediate consideration please press 'apply' now, alternatively contact Arnaud Heroult on +44 (0)203 096 4712 and get more information about the role. 

Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 096 4712.

Fancy getting rewarded?

We find that good people know good people. So when you recommend a friend to SRG and we place them in a contract or permanent job, you could earn a bonus of up to £1,000 of Red Letter Days vouchers as a thank you.

https://www.srg.co.uk/en/job-seekers/referral


The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency

 

Key words: CRA, Clinical Research Associate, SCRA, Lead CRA, CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Medical Device, Permanent, Freelance, Contract, Full-time, Temporary, Project Management, Senior, Manager, Site Manager, CPM, Clinical Project Manager, Study Manager, Project Delivery, Clinical Trial Manager, CTM, Study Director, Project Leader, Clinical Development, Global Study Leader, Clinical Site Manager, Clinical Operations, Clinical Team lead, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, hematology, orphan diseases, nephrology, musculoskeletal, endocrinology, gastroenterology, infectuous diseases, Budget, Protocol, Vendor oversight, Vendor managment, Vendor meeting, Line Management, Ethics submissions, Regulatory body

Apply for this job: Global Study Associate Managers (GSAM) - global Pharma - Office-based in Warsaw, Poland

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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