Summary
Date Posted: Wednesday, October 26, 2022 , Base Salary: Not Disclosed

JOB DETAILS:

Responsibilities
• Lead and manage the feasibility process of proposed clinical research studies, utilizing various internal and external data;
• Support program/study, clinical planning and ensure accurate recruitment forecasting to maximize efficient and timely delivery of the CRU’s clinical trials;
• Collaborate with CRU operations, regulatory and clinical teams to support efficient start up procedures and site activation;
• Lead and manage Cancer Centre Grants in collaboration with the AKU grants office: Proactively monitor requirements and deadlines and manage time for responses to program announcements/RFAs or general application submissions;
• Collaborate with the PI and other Cancer Centre collaborating institutions throughout the application process to achieve a professional document for submission. Route and obtain appropriate signatures as required from PI, key personnel, and other departments, or outside institutions and agencies;
• Assist the PI and project team to assemble application prior to submission and ensure timely submission under absolute, unwavering agency and internal deadlines;
• Actively and closely liaise with the AKU Finance and Grants office to monitor grant budgets and costs for approved grants;
• Foster and champion external engagement and networking, serving as a key point of contact for the CRU and its networks, such as research institutions, societies, Contract Research Organizations (CRO), Pharma organizations, Academic institutions, etc.;
• Strategize planned visits to establish site partnerships and follow-up to build network and maximize site performance;
• Lead pro-active stakeholder engagement activities and partnerships to maintain alignment with the wider organization;
• Provide contractual support on all Cancer Centre contracts and agreements. Prepare, negotiate and review complex contracts related to research studies and clinical trials including Clinical Site Agreements, Master Services Agreements, Non-Disclosure Agreements, Materials Transfer Agreements, etc.;
• Ensure contractual documents sufficiently meet regulatory obligations and company policies and procedures;
• Working closely with the Cancer Centre Director, manage engagement with key cancer Centre committees, and the University’s advancement office;
• Manage external communication to mainstream media, internal media communications. Responsible for AKU CRU website content development and management;
• Work closely with the Cancer Centre Director on content development of manuscripts and publications; and
• In liaison with the Research Operations Manager and Regulatory and Administration Manager, support the operations, finance, administration and regulatory facets of the program, the department of Haematology and Oncology, as guided by the Chair.

Qualifications
Requirements
• Must have a Bachelor’s degree in a scientific, or health-related field. A Master’s Degree is a plus;
• Must have certification in Good Clinical Practice and Human Subject protection;
• Have not less than five (5) years’ experience in clinical research setting, including academic institutions, pharmaceutical industry, Contract Research Organization (CRO) or other clinical research environment;
• Must have strong knowledge of ICH/GCP guidelines, and of protocol and clinical drug development, processes, clinical study design, study planning and management, and monitoring;
• Proven project management skills and study leadership ability are key for this role; and
• Must have excellent computer skills, especially in Microsoft Excel, PowerPoint, Outlook, and Word.

Knowledge and Competencies (skills, abilities & traits required)
• Excellent interpersonal, written and verbal communication skills, and administrative skills
• Demonstrable Leadership skills and drive
• Strong presentation, analytical, problem-solving, decision making and conflict resolution skills
• Ability to multitask, and to work independently
• Excellent report writing skills
• Strong interpersonal and public relations skills
• Broad and strategic thinking

Work Hours: 8

Experience in Months: 48

Level of Education: Bachelor Degree

Job application procedure

Interested and qualified? Go to https://aku.taleo.net/careersection/ex/jobdetail.ftl?job=220001EX&lang=en& to apply


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