Data Capturing Jobs in Johannesburg – Regional Trial Manager

Job Description:

The position is responsible for coordination of clinical trial management activities for outsourced and/or collaborative trials from start-up through study closure in alignment with the Janssen Standard Operating Procedures and applicable Health Authority Regulations in the Sub- Saharan Africa region.

Job Responsibilities:

• Demonstrates deep knowledge of global (ICH) and different local regulations and guidelines in SSA, as well as Janssen Policies, SOP’s and study protocols
• Supports Review and approval of the Local IMP label; manage local depot quality and issue handling; identify import license requirements and support IMP import
• Contribute to local GPP implementation based on central GPP guidelines, and practical GCP experience/adherence. May contribute to local community engagement strategies.
• Invests in relationship building with local stakeholders to strengthen and optimize the regulatory framework for clinical research including Genetically Modified Organism based IMP and Material Transfer Agreements for biological samples
• Assesses the need to build capacity and contributes to capacity building where needed, including follow up on basic infrastructure building for site, local lab and/or local pharmacy/depot
• Helps Ensure appropriate safety reporting procedures are in place per Janssen Policies, and applicable local regulations, and acts as liaison to Global Medical Safety (GMS) and Local Safety Officer (LSO)

Job Requirements:

• BS degree or equivalent required, preferably in Medical or Life Sciences (e.g., Medical Doctor, Biology, Chemistry, Biochemistry, Nursing, PharmD),
• Willing to travel up to 50% of time
• Should be flexible and have experience and ability in managing regional teams both in resource limited settings (if applicable) and in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is required.
• Knowledge of global and regional regulatory environment and regulations (Sub-Saharan Africa)
• Strong experience in mentoring/coaching and providing training to local teams, such as CRO representatives, partners and site staff. Demonstrated ability to lead initiative/small teams.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness.
• Requires clinical research operational knowledge, strong project planning/management and effective communication skills.
• Strong leadership skills. Solid communication and computer skills required. Proficient in speaking and writing English language. Excellent written and oral communication skills.
• Minimum of 6 years clinical trial management experience however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Specific therapeutic area experience may be required depending on the position.
• Strong analytic skills and effectiveness in seeking solutions to issues.

Job Details:

Company: Johnson & Johnson

Vacancy Type: Full Time

Job Location: Johannesburg

Application Deadline: N/A

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