Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Senior Clinical Research Associate/ Country Clinical Quality Manager - Vienna, Austria

Company: Covance
Location:
Reference: 69051BR
Closing Date: 19 Jul 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Do you know Covance is one of the most stable, fastest growing global Contract Research Organization? For example, our Clinical Development teams have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.

Requirements:

This position combines the role of a Country Clinical Quality Manager and Senior Clinicla Research Associate. You would work within our Phase II-IV Flexible Solutions division, working directly with pharmaceutical companies. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.
This is a home base role but you would need to visit the office reguarly in Vienna.

Duty Highlights:

  • Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
  • In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
  • Local expert for any quality-related local processes.
  • Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or headquarters (if necessary).
  • Leads continuous improvements activities at the country level and supports or co-leads continuous improvements activities at the global/regional level.

Training:

  • Local training point of contact and the liaison between local country operations.
  • In close cooperation with local country operations management, identifies local training needs and initiates local training activities.
  • Supports onboarding of local country operations personnel (quality-related topics).

Quality Control (QC) Activities:

  • In conjunction with the local country operations management, coordinates and oversees all QC activities (local quality plan) by ensuring a proper execution of the In-house Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs).
  • In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs).
  • On a regular basis and in collaboration with local country operations, looks into local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

  • Primary point of contact for MRL Quality Assurance and Regulatory Agencies.
  • Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
  • In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
  • On a regular basis and in collaboration with local country operations, looks into local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required)

Quality/ Compliance Issue Escalation:

  • Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM
  • If indicated, escalates quality/compliance issues to MRL Quality Assurance and/or MRL Compliance
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary
  • MRL Compliance Steward (if applicable).ring of results and training of local country operations, if required).

Clinical Supplies GCP Investigations:

  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).

Vendor Qualification:

  • Leads local vendor qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors.
  • Supports the Quality Management System (QMS) assessment for global and local vendor qualifications.


Experience:

  • Excellent project management and organizational skills.
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
  • Ability to analyze, interpret, and solve complex problems.
  • Ability to think strategically, objectively and with creativity and innovation.
  • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.
  • A minimum of 6-8 years of relevant Experience in clinical research including direct field monitoring Experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
  • Demonstrated Experience leading cross-functional teams of business professionals.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Ideally, Experience in managing audits and inspections.
  • Ideally, Experience in coordinating and delivering training sessions.

Skills:

  • Superior oral and written communication and people management skills


Education:

  • Life Science degree


Other Information:

  • These roles are full time & permanent positions employed through Covance.


Key words:

Clinical Research, CRA, SCRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate,CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Austria, Vienna.

 

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Apply for this job: Senior Clinical Research Associate/ Country Clinical Quality Manager - Vienna, Austria

Contact Information:

Address:  Covance- Warsaw


Poland
Tel: 
Fax: 
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.