Current Opportunities at MSD

Job Description

• Are you a seasoned Clinical Research professional seeking a new and exciting challenge? We are looking for a dynamic and experienced Senior Clinical Research Associate to join our team. If you have a passion for driving clinical trials to success, ensuring regulatory compliance, and making a meaningful impact in the field of healthcare, we want to hear from you. Join us in our mission to advance medical research and bring life-changing treatments to patients around the world.

Brief Description of Position:

• The role is accountable for performance and compliance for assigned protocols and sites in a country.
• Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• Could perform Quality control visits if delegated by other roles and trained appropriately.

Experience Requirements:

Required:

• Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:
Preferred:

• B.A./B.S. with strong emphasis in science and/or biology.
   

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Job Description

• The Technical Manager for the Pig and Poultry team is responsible for all technical veterinary support to the company's Animal Health Pig and Poultry team and customers.

The job scope includes:

• Technical support of all products in the portfolio, including networking with global product/technical managers on new material, trials etc, as well as networking with industry KOLs responsible for various diseases.
• Technical support to all P&P team clients/customers in South Africa and Sub-Saharan Africa.
• Technical support to the P&P Key Account Managers to ensure sales targets are met, whether supporting required trials, analysing product data, driving data collection, identifying opportunities to drive sales.
• Technical support to the P&P marketing team to ensure marketing materials have relevant and correct technical data, assisting in creating new marketing material as necessary.
• Training for internal P&P team to ensure team knowledge and technical skills are of the highest quality.
• Training for clients/customers and veterinarians in the industry on diseases and products as required for events or ad hoc.
• Technical support for veterinarians in the industry and territory, in the form of ad hoc communication, answering of queries, training where required.
• Technical support to the BUM for P&P to ensure department strategies are met.
• Managing laboratory services and monitoring projects for the team, ensuring the correct lab partners are used/sourced, timeous submissions of samples and correct and effective interpretation and communication of results to team members and clients.
• Managing laboratory services and monitoring budget, allocating tests as per strategies and monitoring efficacy.
• Managing the pharmacovigilance for the department, addressing PV related issues, resolving queries and working with the PV team to ensure good handling of cases and closing of cases effectively.
• Assist BUM and regulatory department with new product registrations as well as marketing department with launch of new products.
• Compile necessary training materials (for internal and external use) for products/diseases, compile necessary marketing material in co-operation with marketing team. Participate in necessary public appearances to present such materials.
• Technical support on farm to Key Account Managers and clients where necessary.

Requirements for education, skills and experience include:

• BVSc degree (Veterinary degree).
• At least 5-10 years’ experience in the field of poultry disease management or poultry production.
• Good time management skills required.
• Commercial experience will be beneficial.
• Highly flexible and agile.
• Able to prioritise projects well.
• Ability to manage multiple ongoing projects.
• Good excel skills to manipulate raw data will be beneficial.