Clinical Project Specialist (MBBS)

Responsibilities:

• Assists project teams with selective aspects of trial management from start-up to close-out on one or more projects.
• Act as Subject Matter Expert for designated clinical system or task, as assigned.
• Provides support with set-up, access requests, and maintenance for project systems (e.g. CTMS, EDC, Shared Drive).
• Maintains and updates project-related data in an existing database, (e.g. CTMS, DMS) contacting internal team members to gather information.
• Assists with the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations).
• Assists with the adaptation of Informed Consent Form templates at site level, dependent on regional variances.
• Assists with the development of and updates to projects-related plans and site manuals.
• Compile project-related packages (e.g. for IP release, regulatory submission).
• Assists with implementation of protocol amendments.
• Assists with potential site identification and facilitates site outreach activities for feasibility projects (e.g. CDA execution, Feasibility Questionnaire completion by site).
• Administers, reports and reconciles site payments.
• Develops Investigator Grants.
• Supports contract and budget negotiations with sites.
• Coordinate translation of project documents acting as primary contact with translation vendor.
• Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings).
• Assists with the ongoing management of the TMF ensuring documents are filed appropriately, performs TMF file reviews and reconciliation, creates and tracks TMF action items/findings, and escalates overdue action items, as required.
• Assists with maintaining of project team lists.
• With PM oversight, leads periodic and ongoing review, management and QC of project specific training records, reporting any missing records to the PM and functional project leads as appropriate.
• Assists in obtaining training documentation from project team members.
• Support project related vendor management activities.
• Executes and distributes reports from various systems (e.g.TMF, CDMS, CTMS, Financial systems, etc.).
• Assists the PM with budget management including tracking out of scope items, performing timesheet or billing approvals in the system, following-up on billing queries and updating the system.
• Provide other project support to functional teams as directed by Line Management.
• Participated in department initiatives focused on process improvement, as assigned.

Requirements:

• Academic qualification of an Associate degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
• Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants.
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Ability to manage time and work independently.
• High proficiency with full MS Office Applications.
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to travel if necessary preferred (approximately 5%)
• High level of competence in English language
• Must have thorough knowledge of clinical research concepts, practices, and FDA regulations, country local regulations, NAFDAC regulations, EU regulations and ICH Guidelines regarding. drug development phases, clinical trials, clinical study design, and data management methods.
• Expertise in clinical operations with demonstrated ability to effectively manage multiple projects and people.
• Proactive problem-solving abilities and follow-through.
• Ability to work in a very dynamic environment of scientifically driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems.
• Self-motivated to maintain expertise in quality and GCP requirements and guidance to ensure that the clinical operations remain compliant with GCP and other global regulatory guidelines or laws.

Remuneration: NGN 250,000