Syneos Life Science Vacancies – Project Specialist Job
Syneos Life Science Vacancies – Project Specialist Job. Latest Job at Syneos Health – Associate Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent – APPLY BELOW
Role : Project Specialist
Location : India-Asia Pacific – IND-Home-Based
Job ID : 23005248
Description :
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job responsibilities :
- Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
- Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
- Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
- Provide administrative support to Project Leads and functional leads.
- Ensure all study documents are archived based on the appropriate guidelines and policy.
- Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
Qualifications :
What we’re looking for
- Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
- Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Ability to manage time and work independently.
- High proficiency with full MS Office Applications.
- Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- Ability to travel if necessary preferred (approximately 5%)
- High level of competence in English language
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Here are some interview questions along with possible answers for Latest Job at Syneos Health – Project Specialist role :
Question 1: Can you describe your experience with setting up, maintaining, and closing out project files and study information in a clinical research setting? Please provide specific examples.
Answer: In my previous role as a Project Specialist at [Previous Company], I was responsible for setting up and maintaining project files and study information for several clinical trials. For example, I oversaw the regulatory document collection process and ensured that Trial Master Files (TMFs) were complete and up-to-date. I also managed the enrollment tracking, monitored Adverse Events (AEs)/Serious Adverse Events (SAEs), and ensured that site supplies were adequately stocked. When it came to Institutional Review Board re-approvals and data queries, I was diligent in keeping everything organized and accessible.
Question 2: How do you ensure timely and effective communication among team members and site staff while working on a clinical research project? Can you share an example of a challenging communication situation you’ve encountered and how you resolved it?
Answer: Effective communication is crucial in clinical research. To ensure timely and effective communication, I use a combination of regular team meetings, status updates, and email correspondence. In a challenging situation, there was once a discrepancy in the enrollment numbers reported by the site staff and our internal records. To resolve this, I promptly scheduled a conference call with the site coordinator to discuss the issue, clarify data entry procedures, and update our records accordingly. This open and direct communication resolved the discrepancy and prevented further issues.
Question 3: Can you explain the importance of adhering to Good Clinical Practice (GCP) and ICH guidelines in clinical research? How have you ensured compliance with these guidelines in your previous work?
Answer: Adhering to GCP and ICH guidelines is crucial because they provide the framework for conducting ethical and high-quality clinical research. These guidelines ensure patient safety, data integrity, and the credibility of study results. In my previous role, I consistently ensured compliance by conducting regular internal audits, providing GCP training to team members, and closely monitoring study activities to identify and address any deviations from the guidelines. Additionally, I kept abreast of regulatory updates to ensure ongoing compliance.
Question 4: How do you handle situations where there are conflicting priorities or demands from different team members or departments? Can you share an example of how you’ve managed such a situation in the past?
Answer: When faced with conflicting priorities, I prioritize tasks based on their impact on the project’s critical path and communicate with team members and stakeholders to clarify expectations. For instance, in a previous project, there was a dispute between the clinical team and the data management team regarding data collection timelines. I facilitated a meeting to discuss the issue, identify common goals, and develop a mutually acceptable timeline that accommodated both teams’ needs. This approach ensured that the project stayed on track while addressing conflicting priorities.
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