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Clinical Development Scientist - REMOTE

Employer
Proclinical Staffing
Location
Homeworking
Salary
Highly Competitive Salary
Start date
30 Jan 2023
Closing date
13 Feb 2023

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Job Details

Proclinical is seeking a remote Clinical Development Scientist for a leading pharmaceutical company.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

  • Supports the responsible clinical scientist or act as the clinical science lead for clinical studies; provides assistance or when asked is able to act independently with all aspects of the maintenance of clinical studies. These will include authoring necessary protocol amendments, providing final QC confirmation of documents, providing scientific oversight in collaboration with the study operations, medical monitor, data management, and biostatistics study team members.
  • Ensures uninterrupted supply of study medication, appropriate safety monitoring, data collection, reporting of regulatory agency required updates.
  • Leads efforts in identifying and implementing solutions to issues.
  • Leads efforts in the combining of clinical studies from various programs into rollover trial(s) and ultimately works with local country colleagues to transition study patients to commercial drug supply.
  • Ensures effective management of the study plan including all activities, budget, and timelines and other related duties as assigned.
  • Ensures effective communications with staff in the regions/countries with regards to study conduct.

Skills and Requirements:

  • Bachelor Degree in Life Sciences.
  • Prior HIV experience is highly desirable.
  • Minimum of 5 years of experience from a CRO or Pharma working in clinical research roles in the conduct of multi-center, international, clinical studies.
  • Understands running clinical trials and clinical training and/or applicable clinical research experience.
  • Knowledge of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes Knowledge of Trial Master File industry accepted standards, such as the DIA's TMF Reference Model.
  • Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records.
  • Excellent interpersonal and communication skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders.
  • Proven record of being customer driven, ability to learn processes quickly, a self-starter, and able to work in independently as well as in matrix team environment.
  • Analytical/logical, with superior organizational skills and attention to details, addresses assignments in a timely and efficient manner.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JC8

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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