- Manages clinical staff whichmay include interviewing and selection job description preparationprofessional development goal setting performance managementbehavioral and technical coaching and mentoring employee counselingand separations. Approves courses of action on salaryadministration hiring corrective action and terminations. Reviewsand approves time records expense reports requests for leave andovertime. Promotes all aspects of Equal Employment Opportunitypolicy and Affirmative Action Plan. Assures department adherence togood ethical and regulatory standards.
- Supports study implementation and involved in theplanning of study delivery at sites to ensure maximum patientenrolment and delivery.
- Drives medicaloperational delivery by embedding and creating a cultureof
- delivery excellence.
- Actively involved in feasibility new trends and studiesand recommend best
- approach at a countrylevel.
- Involved in the planning of studies toensure maximum patient enrolment and
- delivery.
- Cascades global strategicbusiness plan and direction to country/territory.
- Leads the medical teams to develop strategies and tacticsto support planned growth and to increase efficiency andeffectiveness.
- Attends and participates in theweekly delivery calls and give guidance to
- support the achievement of delivery goals.
- Manages and controls costs within agreed budgets whereapplicable.
- Adheres to applicable regulationsand ICH guidelines regarding clinical trials
- regulatory documents and safety issues. Adheres toCOPs/SOPs and study
- specificguidelines.
- Drives compliance with company andsponsor quality objectives ensuring
- effectiveand efficient best practice processes procedures and documentationto aid delivery and meet customer requirements.
- Provides or arrange training to all research physicianswithin the territory (study specific operational standards acuteperformance issues etc.) specifically including conducting patientappointments in the most efficient and effective manner to maximizeresults.
- Provides guidance to researchphysicians regarding the clinical management ofpatients.
- Monitors all safety variables (AELab abnormalities changes in medical status unblinding request) anddiscusses all medical concerns with relevant
- stakeholders.
- Provides sound andpoised review of the likely risks and benefits of a study tomanagement.
- Provides medical review of adverseevents of special interest serious adverse events and clinicaloutcomes events reported by study sites.
- Ensures team focuses on the need and urgency to deliverrandomizations.
- Develops plans with team tofix leading and laggingmetrics.
- Validmedical degree within the country with at least 10 years working asa licensed Physician as well as other medical licences as may berequired within country( i.e. dispensing) and at least 8 yearsexperience working in clinical research with PIresponsibility
- Valid registration as a medicalpractitioner with a medical license in good standing withunrestricted ability to practice in place of work
- Valid ICH GCP certificate
- At least 5years management responsibility if leading ateam
- Strongcritical thinking decision making analytical and problem solvingskills
- Exceptional communication skills andability to work with a crossfunctional team to driveresults
- Demonstrated ability to influence andcollaborate at all levels throughout the organization
- Excellent written verbal and presentationskills
- Strong planning organizational andproject management skills
- Ability to manageoutside agencies in order to fulfil project objectives
- Selfstarter with ability to thrive under pressure in afast paced environment
- Skilled in Word Exceland PowerPoint and proficient with the Internet
- Solid understanding of the clinical regulations as wellas practical knowledge of common local medical practices andtreatment habits
- Ability to work with minimalguidance and proactively seek guidance on complex tasks
- Ability to multitask and operate within a deadline drivenenvironment
- Openminded and dedicated teamplayer who thrives in a dynamic and internationalenvironment
-
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Director Medical Operations - Manchester, United Kingdom - Lifelancer
Description
Key responsibilities are asfollows:
Education andExperience:
Knowledge Skillsand Abilities:
Please usethe below link for job application and quickerresponse.
RemoteWork :
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