Develop the database design requirements which include configuration (project specific kit contents, laboratory events,
requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining
client design standards as applicable in accordance with the requirements of the Clinical Protocol.
Perform database configuration and programming review and approve verification unit testing
Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues
focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen
Responsible for providing updates to the Project Manager regarding action / issues logs, status sheets and timelines during
the start-up phase.
Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are
Lead in the development of sponsor specific standards and program-specific set-up procedures.
Lead in the identification and resolution of service level issues and where issues affect other projects within and across
programs to ensure that any solution is employed universally.
Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing
of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory
specifications document for each protocol within a program as appropriate.
As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.
Participate in external and internal audits as required.
Coordinate and mentor more junior staff; may assist in training new staff.
Report on team performance against contract, customer expectations, and project baselines to management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Possess strong interpersonal skills
Demonstrated ability to meet deadlines.
Demonstrated computer proficiency with Microsoft Office
Working knowledge of Clinical Trials Management Systems would be an advantage examples QLIMs, NewLIMs,
TOPCAT, Encompass .
Possess an understanding of medical and clinical research terminology.
Demonstrated ability to work in a fast-paced, high stress environment.
Knowledge of Project Management processes and terminology.
Excellent organizational and time management skills
Excellent accuracy and attention to detail skills
Strong written and verbal communication skills written & spoken, influencing & negotiating
Excellent inter-personal skills
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or equivalent education and experience; science related background is advantageous but is not
Minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
Job ID : R1085691