Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
Post: Clinical Study Manager/Clinical Operations Manager - 1103225
Job Description:
PURPOSE
Manage the execution of the clinical component of study protocols of low to medium complexity within a region in a single
continent in accordance with the scope of work and contracted timelines. May act as a CTL for large scale projects under the
supervision of a more senior CTL or Line Manager. May also serve as a Sr Clinical Research Associate (Sr CRA) within the
project or other projects as needed.
RESPONSIBILITIES
• Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and
study timelines.
• Manage clinical study set-up and follow-up study activities through ongoing tracking and review of study progress. Report
progress to appropriate clinical management and project management forums.
• Collaborate with other functional groups within the company such as data management, pharmacovigilance, and
biostatistics where necessary to support milestone achievement and to manager study issues and obstacles.
• Provide ongoing training and support to the clinical team. Establish study tools and training materials. Conduct frequent
team meetings and ensure regular communication.
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site
visits and ongoing mentoring of CRA team.
• Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with
the Project Manager.
• Identify quality issues within the study through regular review of the clinical team communications including site
communications, monitoring visit reports, data flow information and quality assurance audit findings. Implement
appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Track clinical budget consumption through regular review of project budget reports.
• Establish customer service relationship with applicable client representative(s) as appropriate.
• May conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced
therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard
operating procedures, good clinical practice, and applicable regulatory requirements.
All responsibilities are essential job functions unless noted as nonessential (N).
Candidate Profile:
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Strong written and verbal communication skills including good command of English language
• Excellent organizational and problem-solving skills
• Effective time management skills
• Strong presentation skills
• Effective mentoring and training skills
• Ability to lead and motivate a culturally-mixed clinical team
• Ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Bachelor's degree in a health care or other scientific discipline or educational equivalent; 3 years clinical monitoring and
one year in a project leadership role ; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Frequent domestic and international travel
Additional Information:
Experience: 3-4 years
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
View Original Notification: Apply online
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