Medical Director
2 months ago
Worldwide 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.
We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
What Medical Affairs does at Worldwide
Medical 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; 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.
Medically 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 assigned
Provide 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 company
Collaborate 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 database
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 management
Strong supervision, interpersonal and communication skills as well as conflict resolution skills and be committed to quality and honesty
Must 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/lectures
A Medical degree (M.with a specialization (board certification) inInternal Medicine or similar field
At least 2 years of medical monitoring in clinical research or related industry
Why Worldwide
To view our other roles, check out our careers page at For more information on Worldwide, visit or connect with us on LinkedIn.
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