• 1Search for courses by Study Area, Level and Location
  • 2We deliver you all the matched results
  • 3Choose one or more course providers to contact you
Industry

Distance from location (kms)

Exact 5 10 25 50 100

Posted since

All 2 Days 1 Week 2 Weeks 1 Month

Sort results by

Relevance Date

18

May

Manager, Clinical Research

Covance - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Job Overview

The CRM is accountable for execution and oversight of local operational clinical trial activities
and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.
The position has a significant impact on how a country can deliver country-specific trial
commitments and objectives especially during the study.

  • Significant impact on the ability to effectively conduct clinical studies and develop the
pipeline, while maintaining local regulatory and compliance requirements in countries. The
position 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 Client with investigators, functional outsourcing partners and
other external partners and therefore have a significant impact on country-level customer
relationships.
  • Requires 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
or Therapeutic Director. Requires strong understanding of local regulatory environment,
country regulations, client policies and procedures, quality standards.
  • Strong scientific and clinical research knowledge is required for this position. A strong
understanding of clinical trial planning, management and metrics is essential as well as the
ability to focus on multiple deliverables and protocols simultaneously. Requires skills to
effectively build and maintain professional relationships with investigators and other
external stakeholders, requiring strong communication, educational/pedagogic, diplomatic
and empathic skills. The role will require proven ability to collaborate and lead high
performing cross-functional teams also in a virtual environment.
  • The position requires strong leadership skills (scientific and business) and ability to
coordinate and lead local teams to high performance. Oversee country commitments,
compliance and training needs. Additionally, business leadership and alignment with
corporate requires that individual has ability to lead across several dimensions
simultaneously.
  • Works collaboratively with Country and Regional Operations; Pharmacovigilance,
Regulatory, Global Medical Affairs and Global Human Health internally; and with external
functional outsourcing vendors. Requires coordination and alignment with the regional and
broader organization. Additionally, will work to build and maintain relationships with
investigators and other external partners and promote Client’s reputation. In collaboration
with CRD, represents Client in Pharma industry issues and in seeking influence in external
R&D environment.

Minimum Required

Education/Qualifications:

♦ University/college degree (life science preferred), or certification in a related allied health
profession from an appropriately accredited institution, nursing certification, medical or
laboratory technology
♦ In lieu of the above requirement, candidates with minimum of four (4) or more years of
relevant clinical research experience in pharmaceutical or CRO industries or experience in a
health care setting will be considered
♦ Thorough knowledge of ICH Guidelines and GCP including a basic understanding of

Regulatory Requirements In Other Countries

♦ Thorough understanding of the drug development process
♦ Fluent in local office language and in English, both written and verbal

Experience

Minimum Required:

♦ Good organizational and time management skills
♦ Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other
applicable regulations/guidelines; familiarity with investigator start up documents; previous
interaction with operational project team and investigative sites preferred.
♦ Excellent communication skills, oral and written.
♦ Self-motivation with the ability to work under pressure to meet deadlines
♦ Works well independently as well as in team environment.
♦ Detail and process oriented
♦ Positive attitude and approach
♦ Interact with internal and external customers with high degree of professionalism and
discretion
♦ Multi-tasking capability.
♦ Good computer skills with good working knowledge of a range of computer packages
♦ Ability to lead and develop junior staff
♦ Flexible and adaptable to a developing work environment
♦ Minimum of six-eight (6-8) years of clinical research experience

Covance is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

Sydney, NSW

Health, Medical & Pharmaceutical




APPLY

Shortlist Job

;