Job Opportunities at MSD

Brief Description of Position

• With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. 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
• 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 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.
• Supports audit/inspection activities as needed.
• Performs co-monitoring where appropriate. 

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Job Description

• Admin Assistant to provide support to Medical Affairs team with administrative projects for a fixed term period. The duration of the contract is twelve (12) months. The role will be based in Midrand. This role will report to Medical Affairs Director.

The job duties include the following:

• Arrange access and business cards for New Employees
• Order stationery for all Team members when its needed (Medical Affairs)
• Organise monthly department meetings
• Manage events for Medical
• Take minutes for all our meetings
• Set-up meetings for NHI WG and taking minutes for every meeting
• Book and request travel for team members (Medical Affairs)
• Get quotation from travel Office check if all dates and times are correct and send to the travel to confirm if all is in order

Admin

• Loading content and users on our medical education Platform (Digi-CME)
• Provide guidance on Expenses queries for the team
• Upload important documents on Microsoft Teams and onto share drive
• Design, functionality implementation and uploading of pioneer GMSA diversity & Inclusion newsletter 
• Generate purchase orders for all vendors that falls under PO based vendors on SAP/COMET and manage process end to end
• Getting approval from managers before loading the PO on Comet
• Issue PPR for Invoices to Finance for payment and follow up appropriately
• Approve PPR as a first line approver for medical department which are issued by another department i.e. Regulatory
• Load new vendor on MDG

Compliance

• Create Events on Salesforce on behalf of medical team and submit for approval
• Check all the information submitted to ensure that all required documents are valid (FCPA, Quotes, Contracts, DDQ, etc)
• Route the request to the approvers
• Creating Contract agreement for HCP that will participate in the organisations' events
• Assist in getting approvals for Events documents that requires approvals from Managers, Directors and MD
• Complete and close the events on Sales Force and create note to file if needed (6 weeks after the event)
• Submit deviations/note to file for approval
• Working with Compliance in submitting all quarterly events

DPCO and medical information

• Ensuring accurate recording and reporting of inquiries on the IRMS system
• Ensure timely management of medical information requests by routing of MIRs to Mobil Saglik for handling
• Appropriate routing of inquiries to PV and quality
• PV, PQC MI collaboration, Process assurance, keeping timelines
• Monthly PV Reconciliation and sign off
• Providing monthly reports to the medical team 

Education and Experience Requirements:

• Matric
• Accredited Diploma/Degree in Business Administration or equivalent will be an advantage
• SAP knowledge will be an advantage
• Excellent proficiency MS office packages (MS Word, Power Point, Excel, Teams and Outlook)
• Good communication skills
• At least 3 years’ experience in Admin Support environment

Secondary Language(s) Job Description:

Education and Experience Requirements:

• Accredited Diploma/Degree in Business Administration or equivalent will be an advantage
• SAP knowledge will be an advantage
• Excellent proficiency MS office packages (MS Word, Power Point, Excel, Teams and Outlook)
• Good communication skills
• At least 3 years’ experience in Admin Support environment.

Required Skills and behavioral attributes:

• Ability to prioritize and handle pressure
• Highest ethical standard and confidentiality
• Exhibit a methodological and organized work routine, but flexible enough to adapt to change
• Familiarity with would be an added advantage
• Ability to work in cross functional team
• Communication skills
• Strong problem-solving skills
• Ability to work in high performance teams, and in a matrix organization.  Ability to negotiate and influence others.
• Excellent team player; must excel at teamwork in cross-functional groups.  Must be able to interact successfully with a variety of individuals at the local level, including Medical Advisors working in different therapeutic areas, MRL teams, commercial teams and contract research organizations (CROs).