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The following message was posted to: PharmPK
Experienced CRAs can fast develop project management skills working
across functions & with vendors as well. A role in Early Phase
Development is the optimal way to learn to manage multiple components
from protocol design to reporting. CSL assigned permanent role with a
World Class pharmaceutical company renowned for its contribution to
Global Healthcare.
Introduction:
This is a strategic career step for an able CRA or PSM with Phase I
experience and a sound science background who is now seeking to jump
the hurdles and gain project co-ordination, protocol design & vendor
management expertise. Taking this step for up to 18 months can
accelerate your career path into study leadership at international
level and gain you credibility based on successful working within a
global matrix. Why wait around managing sites when you can move to
one of the top companies now & be well supported by a company that
takes care of career planning and open doors for you!
You will join our clients global clinical pharmacology and study
management group and build on your current or allied skill to take
responsibility for clinical operations functions (planning,
coordination, initiation, conduct, monitoring and evaluation) for a
series of early clinical development studies within a program. You
will combine experience in clinical development processes and learn
how a cross-functional Study Management Team (SMT) works in a matrix
setting.
Summary of Duties:
Team Leadership and Management
Team Leadership and Management responsibility for all aspects of the
study following protocol approval. This will include planning the
study, setting timelines and communicating all decisions to the Study
Management Team (SMT). The PSM will also be responsible for ensuring
that roles and responsibilities are fully understood by the team and
to motivate them to deliver the study in accordance with the
timelines you have set.
Study Planning
Responsibility for the operational planning of the study to include
investigator and site selection, CRO and/or analytical laboratory
selection, drug supply, contracts, budgeting, source document
verification plan, data flow plan and safety monitoring. You will
assist in the development of the protocols, developing case report
forms (CRFs) and the preparation and management of the budget/
financial plan including overall study cost, contract negotiations
and preparation, payment schedule, tracking and budget adjustment to
meet study requirements. The PSM will also provide operational
planning (including input to protocol and CRF) and support (supplies
and training) to SMTs for Phase II to IV studies that include
pharmacokinetic, genetic, diagnostic and pharmacodynamic sample
collection.
Study Implementation and Conduct
Study management at an international level including supply
management, budget and contract negotiation, initiation, monitoring
and closedown in accordance with current Standard Operating
Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.
For further information please contact Ann Maloney on 01932 228928
or send an application mail to: ann.-at-.cslrecruitment.com and quote
reference no. 3360.
Qualifications Required:
* Bachelors (or Masters) degree or equivalent in a biomedical, life
sciences or nursing discipline.
* A minimum of 2 years experience in the planning, development,
conduct and monitoring of clinical or clinical pharmacology studies.
* Critical reasoning skills including the identification and
resolution of complex problems
* Effective management of cross-functional teams, including
delegation of tasks
* Supervisory and highly effective interpersonal skills
* Excellent planning and organisational skills
submitted by ann.-at-.cslrecruitment.com
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)