Clinical Research Manager - Australia (Home Based) - Permanent Contract
Clintec is actively recruiting for a Clinical Research Manager to join our expanding global company. This is a home based role however you will be required to visit the office in Sydney a few times per month (as and when required). By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Clinical Research Manager (CRM) has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent our sponsor with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.
The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director.
- The is CRM accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).
- The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
- The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
- The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents our sponsor in Pharma industry issues and in seeking influence in external R&D environment.
- The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization.
- The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
- Bachelors Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience with CRA experience is highly preferred
- Knowledgeable about the drug development process, ICH-GCP and Local Regulatory Processes
- Significant previous experience in a similar level/type of role
- Expert in clinical trial monitoring with recent practical hands on experience and the proven ability to coach, mentor and motivate others in this discipline
- Excellent communication skills including the ability to interact with clients and team members at all levels
- Good presentation skills in keeping with Clintec
- Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed
- Fluent in English language
- Ability to travel to the office in Sydney as and when required
Clintec is a UK-based, dynamic privately owned full service Contract Research Organization with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries for over a decade and assist in their key product development efforts. At Clintec International, we pride ourselves on delivering high quality, flexible and professional services/solutions for our clients. Clintec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects - with the opportunity to develop, progress and travel globally. Clintec International offers a competitive salary and rewards package.