Overall purpose of the position:
To manage TASK Applied Science clinical trials data through review, computerization, cleaning and auditing of clinical data in compliance with standard operating procedures, client guidelines and regulatory guidelines.
Key performance areas (KPA’s) & responsibilities
Assist in the maintenance of Data Management study files.
Represent the CDM team on the project team.
Perform data management tasks, pertaining to the Data Management Plan.
Perform quality control procedures.
Assist other team members in training and developing data management expertise.
Understand and comply with core operating procedures and working instructions.
Perform other duties as directed by the Functional Manager.
Meet objectives as assigned.
Holds accountability for delivery of Customer requirements as documented in the contract and Data Management Plan.
Acts as primary contact for Customer and internal contact for PM, Clinical Operations, Biostatistics and DM Ops for assigned projects.
Works with overall project team (i.e. Customer, Project Management, Clinical, DM Ops & Biostatistics as needed) in defining DM timelines/deliverables for the project.
Coordinates production, review and authorisation of the CRF design.
Drafts the DMP documents, coordinates the review and obtains authorisation for all DMP documents.
Responsible for ensuring the DM Project Tracking Database is accurate and current for assigned projects.
Communicates ongoing project deliverables to DM Ops and ensures adequate progress is being made toward deliverables.
A B.Sc degree in bio-medical or bio-statistical; or relevant data management experience
Knowledge of ICH-GCP with a strong interest in clinical research
Experience in working with databases
Professional use of the English language; both written and verbal
Clinical trial systems knowledge e.g. Clintrial or Clindex
Advanced PC skills
Leadership and behaviour:
Delivering high performance and an excellent communicator who listens effectively and accurately and clearly conveys information through verbal and written means.
Driving quality by displaying ability to clarify and reduce complex issues to simple solutions.
Ability to anticipate problems and resolve problems before they occur.
Recognize recurring issues and analyse their causes in order to reach a solution
Excellent planning & organising skills with the ability to work systematically and sequentially.
Personal effectiveness and the ability to work in a pressurised environment.
Maintain good relationships with colleagues and customers.
The ability to adapt working hours, key outcomes and competencies in response to the business needs which may change from time to time in response to strategies and operational requirements
Area: Bellville, Cape Town
Salary Bracket: Market Related
Type of Employment: Permanent
Starting Date: ASAP
Positions Available: 1
APPLICATIONS CLOSE: 20th January 2018
Please indicate in your application that you are applying for the above-mentioned position:
REF: DATA MAN