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Project Manager
ClinSoft
15 Jan 2021
| Company: | ClinSoft |
|---|---|
| Duration: | Long-term |
| Start Date: | ASAP |
| Deadline: | 31 January 2021 |
JOB DESCRIPTION :
ClinSoft is looking for a proactive, highly productive and accountable Project Manager to join its team of professionals of data analytics and technology solutions. Reporting to the Chief Scientific Officer (CSO), the successful candidate will work on managing all aspects of project team activities for assigned projects and will be jointly accountable for achieving successful delivery of ClinSoft’s project team activities at project level by meeting the Company and regulatory requirements according to time, scope and quality.RESPONSIBILITIES :
- Provide overall coordination and management of projects from start up through close out activities;- Work with major functional area heads and project leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure implementation of solutions;
- Provide leadership in determining project activity priorities, timelines, plans, designs, and execution of projects;
- Ensure project implementation adherent to specified objectives, internal standard operating procedures (SOPs) and regulatory requirements (U.S. Food and Drug Administration (FDA) regulations, Good Clinical Practices (GCP), the Health Insurance Portability and Accountability Act (HIPAA), International Committee on Harmonization (ICH) Guidelines, etc.;
- Assist with development of project study design, protocols, case report forms and other study-specific documents and submissions (Request for Proposals (RFPs), deliveries, regulatory submissions, etc.) essential to appropriate implementation of projects;
- Monitor the progress and the completion of projects;
- Manage project requirements, including deadlines and schedules;
- Act as the primary contact person, establish and maintain excellent working relationships with Client representatives and other project partners;
- Maintain compliance with all Company policies and procedures;
- Perform other job-related duties as assigned by the CEO and/ or CSO.
REQUIRED QUALIFICATIONS :
- University degree in Life Sciences, Statistics, Biostatistics, Information Technology, Business Administration or a related field; PhD degree is preferred;- At least 5 years of project management experience;
- Experience in pharmaceutical, biotechnology, medical device or contract research organisation (CRO) industry is preferred;
- Knowledge and understanding of clinical research concepts, practices, and FDA regulations, GCP, HIPAA and ICH Guidelines, clinical research and data management is preferred;
- Good understanding of statistics and marketing;
- Ability to be productive and successful in an intense work environment;
- Ability to make priorities, quickly adapt to study changes and work under pressure and tight timelines;
- Strong attention to detail and delivery of accurate and high quality work;
- Ability to handle sensitive and confidential information;
- Excellent knowledge of English language;
- Strong communicator with excellent verbal and written communication skills for interacting with external Clients, especially in English language;
- Ability to be proactive and work independently;
- Willingness to work flexible schedule;
- Team player with excellent interpersonal skills and problem-solving ability;
- Innovative thinker.
APPLICATION PROCEDURES :
Interested candidates are welcome to apply online via careercenter.am or send their CV and motivation letter to: hr@clinsoftcsd.com mentioning the applicant's email address and the title of the position ("Project Manager") in the subject line of the e-mail.Please clearly mention in your application letter that you learned of this job opportunity through Career Center and mention the URL of its website - www.careercenter.am, Thanks.
