Ref #: 27911

Employment type: Permanent - Full-Time

Location: Australia & New Zealand

Posted: 24-Mar-2021

Description

We are calling for people who care and have passion in improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At DOCS-ICON, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.


Key Responsibilities:


* You will be the Primary point of contact. Acts as ambassador for the company and contributes to making the company the preferred partner.
*Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, the company’s procedures and protocol requirements to ensure data quality and study subject protection.
*Responsible for managing the site to meet patient recruitment rate and target.
*Delivers results that have direct impact on the successful completion of the clinical programme.
*Coordinates with LTM and RTM and communicates to them progress and critical issues that may impair trial progress.
*Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
*Identify potential risks and proactively take action to prevent or mitigate
*Collaborate with Data Management/logistics in resolving queries
*Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
*Manage trial product requirements, incl. temperature deviations and training of site staff
*Motivate and build strong relations with site personnel to ensure the company is the preferred clinical research partner
*Ensure collaboration with and deliverables from vendors locally, if applicable
*Collection and management of essential documents
*Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
*Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable


Requirements:

*At least B.Sc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region
*Ideally experience from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO). Other experience may also be relevant, e.g. as study staff at a clinical research site.
*Ability to build and maintain relationships with sites
*Excellent communication and negotiation skills
*High focus on delivery and quality
*Adequate English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports
*Proven decision making and problem solving capabilities
*Ability to manage multiple priorities
*Team oriented personality with high degree of flexibility
*Ability and willingness to adjust quickly to new situations in a continuously developing environment