Job Description
Title: Assistant Manager, Operations
Company Name: Bangladesh Clinical Trials Limited (a sister concern of JMI Group)
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ Master in Biochemistry/ Biotechnology
Experience Requirements:
∎ 5 to 8 year(s)
∎ The applicants should have experience in the following area(s):
Clinical trials, Medical Research
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
Job Responsibilities:
∎ Monitoring the process of clinical trial in relation to the project plan and previously defined performance indicators in terms of quality and budget.
∎ Act as a daily point of contact for the sponsor/ client and all members of the project team.
∎ Prepare independently clinical trial submission dossiers for Regulatory and Regulatory Authorities, including Import and Export license applications.
∎ Communicate with regulatory authorities, project teams and vendors on regulatory-related matters.
∎ Review translations of essential documents subject to clinical trial submission.
∎ Track the regulatory project documentation flow.
∎ Review documents to greenlight IP release to sites.
∎ Manage safety reporting to authorities.
∎ Deliver regulatory training to project teams.
∎ Assist with feasibility research and business development requests
∎ Supervise Regulatory Affairs staff in the country
∎ Managing project finances in accordance with the (Sponsor) contract and budget.
∎ Reporting the progress to the internal project team, and if applicable external stakeholders.
∎ Building the cross-functional project team and lead their efforts for overall project delivery to support milestone achievement.
∎ Performing quality reviews of the TMF and all project documentation as per policy.
∎ Negotiating contracts with research centers and suppliers.
∎ Forecasting and identifying opportunities to accelerate activities to bring revenue forward.
Additional Requirements:
∎ Age 28 to 38 years
∎ Both males and females are allowed to apply
∎ Should be proficient in the use of computer, e.g. MS Word, Excel, Internet, etc.
∎ Must be Fluent In English (Oral & Written)
∎ The candidate must be proactive and creative in order to formulate/implement efficient & effective business techniques.
∎ Must be proactive and creative.
∎ Good interpersonal communication skills
∎ Frequent movement is mandatory.
∎ Experience in clinical trial roles.
Salary:
∎ Negotiable
∎ As per company policy
Compensation & Other Benefits:
∎ Mobile bill, Provident fund, Weekly 2 holidays, Insurance
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ Annual Leave Encashment.
∎ Bangladesh Clinical Trials Ltd. offers excellent working environment, attractive compensation package and performance-based career progression to the deserving candidates.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 30 Sep 2023
Company Information:
∎ 21 Sep 2023
∎ Bangladesh Clinical Trials Limited (a sister concern of JMI Group)
Category: Medical/Pharma
: Please apply through online. We discourage hard copy of application.
