Worldwide Clinical Trials

Senior Medical Director - CNS - EU (home based)

home based
03 Dec 2018
03 Jan 2019


? Medically manages clinical trials to which s/he is assigned as MM
? Serves as Global Lead MM (GLMM) for pan-regional and/.or global trial(s) to which s/he is assigned
? Collaborates with the other members of the Medical & Safety project team to process Serious Adverse Events (SAEs)
US: when contracted might conducts and document an Analysis of Similar Events (AOSE) included as part of the case narrative, in keeping with FDA 21CFR312.32
? Provides therapeutic and protocol-specific training to the project teams
? Contributes medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc
? Provides after hours medical support for projects to which s/he is assigned
? Independently supports 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
? Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) as directed by senior management
? Maintains 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
? Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
? Identifies, documents and appropriately resolves out-of-scope work as directed by senior management
? Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management
? Maintains working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards
? Mentors other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company

? Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures
? Demonstrates competence with the execution of SAE related medical review in WCTs electronic safety database
? Excellent computer skills (Word, Excel, Access)
? Excellent organizational and time management skills
? Excellent communication skills
? Excellent presentation skills
? Customary office desk and managerial work, no heavy lifting, occasional business travel
? Medical Degree from an accredited institution of Medical Education.
? 6-8 years clinical research or industry experience


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