September 26, 2024

Jamjoom Pharma

جدة

FULL TIME

Associate Manager – Bioequivalence

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
Role Summary:
The Associate Manager – Bioequivalence is a critical position within the R&D Operations team and is assigned as a study lead to manage clinical trial studies. The position will partner with research scientists and to support activities on clinical trials like bioequivalence studies and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Associate Manager - Bioequivalence will work to manage, oversee and may monitor/co-monitor clinical trial sites.
Responsibilities:

To conduct Feasibility Studies of Clinical studies. Discuss and negotiate budget with CROs, Perform CRO Selection in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
Participate and facilitate cross-functional study teams, liaise with other functional areas to accurately coordinate clinical study activities.
Coordinate clinical study timelines to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.
Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. Oversee and manage clinical documentation and reports.
Provide regular updates of study progression; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
Participate in developing study plans, protocols; participate in preparation and ensure operational excellence of protocol, and other key study deliverables.
Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data; maintain clinical study files per SFDA, ICH and GCP guidance. Ensure strict adherence to local and international regulatory guidelines governing clinical research.
Maintains project timeline, conducts risk assessment/mitigation and contingency planning.
Contribute to the development and refinement of study protocols for BA/BE research.
Supports/assists with oversight and accountability of all third-party CROs and vendors.
All work must adhere to SFDA/ICH/GCP guidelines and comply with company SOP's
Review vendor / site invoices in a timely manner. Propose annual budgets for bioequivalence studies and clinical studies as per the project plans.

Qualifications & Requirements:

M. Pharm. or Ph.D. in Pharmacology or Clinical studies.
Minimum of 10 to 15 years’ experience as Associate Manager or equivalent in the pharmaceutical / biotech or CRO industry
Must have a strong knowledge of SFDA / GCC/ USFDA/ICH / GCP guidelines.
Comprehensive understanding of the drug development process.
Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
Proficient in oral & written communication skills.
Proficient in Microsoft (Excel, Word, Outlook).
Proficient in Win Non Lin Software and pharmacokinetic statistical calculations.
Preferred Knowledge of SAAS software.