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Medical Director Medical Affairs - Perth, Australia - Worldwide Clinical Trials, Llc
Description
Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.
Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries.We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers.
From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
Join usWhat Medical Affairs does at WorldwideMedical Affairs impacts every stage in the lifecycle of a clinical investigation.From Business Development to Regulatory Submissions, members of the MA team support the larger project team, and help establish the medical orientation that characterizes the philosophy here at Worldwide.
Activities include direct interactions and presentations with medical and operational personnel from pharmaceutical companies in the process of business development; protocol preparation and country specific feasibility assessments for proposed investigations that inform study design and operational metrics; training of investigative site staff and members of Worldwide project teams on medical or assessment methodology unique to a given study, and the medical monitoring of adherence to enrollment criteria for study candidates as well as medical management activities for patients during the course of the trial.
A pharmacovigilance activity for adverse event analyses and reporting is an integral part of the service offering.Medical Affairs also partner with other functional groups within the Worldwide organization for the design and execution of "first in man" studies (CEDRA), the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of regulatory submissions such as investigative new drug applications which permit the initiation of clinical testing.
What you will doMedically manage clinical trials to which s/he is assigned as Medical Monitor, serve as Global Lead Medical Monitor (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned; provide after hours medical support for projects to which s/he is assignedProvide therapeutic and protocol-specific training to the project teams; contribute medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc.; as directed support Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management; assist in the annual attainment of departmental revenue targets and any other activities as directed by senior management; assist in the mentoring of other medical staff) as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, supports Senior Management's leadership of both the department and the companyCollaborate with the other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs); demonstrate competence with the execution of SAE related medical review in WORLDWIDEs electronic safety databaseReview and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc.,) as directed by senior management; maintain a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc), review of relevant therapeutic/clinical literature and attendance in conferences and meetings; interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects; identify, document and appropriately resolve out-of-scope work as directed by senior managementWhat you will bring to the roleStrong supervision, interpersonal and communication skills as well as conflict resolution skills and be committed to quality and honestyMust possess exceptional organizational and planning skills and good documentation skills.
Must be punctual and have a flexible work schedule.In-depth knowledge of the clinical research process, including Good Clinical Practices.
Working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards.
Clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lecturesAble to make good, sound decisions under stress and time constraints.
Your backgroundA Medical degree (M.D.) with a specialization (board certification) in Internal Medicine or similar fieldAt least 2 years of medical monitoring in clinical research or related industryWhy WorldwideWe love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at For more information on Worldwide, visit www.or connect with us on Linked In.#LI-FD1#LI-remote#J-18808-Ljbffr
