Manager - Clinical Research Operations

POSITION DESCRIPTION

Role / Position Title - Manager – Clinical Research Operations

Department/Function - RnD

Region / City - Mahwah, NJ

FLSA (Exempt/Non-Exempt) - Exempt

Hours - 8 a.m. to 5 p.m. in office 3-5 days per week

POSITION SUMMARY

Responsible within Clinical Operations to manage the planning, outsourcing and successful delivery of Phase I to Phase III Clinical Trials for Glenmark’s innovative medicine pipeline in USA with due guidance and support from the Lead Clinical Project Manager and Clinical Lead.

OVERALL JOB RESPONSIBILITIES

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• To identify and develop relationship with Global CROs for IMG Phase I to Phase III Clinical & PK studies within USA
• To manage outsourcing of Phase I to Phase III studies including management of CROs, contracts and other vendor management activities
• Monitor expenditure of funds relative to budgetary targets and oversee the progress of Phase I to Phase III studies with respect to timelines, quality and cost.
• To review overall study plans, project management plan, monitoring plan and to perform random quality checks of study operations, monitoring activities etc.
• To develop and maintain sponsor oversight file for each outsourced Phase I to Phase III Studies.
• Ability and willingness to travel approx. 25% or as required - for conducting site selection, initiation routine monitoring and accompanied monitoring visits.
• Provide input to Line Manager/HOD, Participate in efforts to ensure that all trial related expenses are accurately and appropriately recorded.
• Liaise with Global Project Manager, Clinical Operations, Clinical Sciences, DMPK, CMC Regulatory Affairs and Clinical Pharmacology for planning and oversight of Clinical & PK Studies.

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Graduate/Post Graduate with B. Pharm, or Medical Degree or other life sciences qualification with relevant experience.
• A deep understanding of the drug development process and handling operations at a clinical sites in US is essential.

Experience

• Minimum of 5 years of Healthcare/Bio-Pharmaceutical management experience of which at least 3 years should be purely in managing Oncology clinical trials.
• The candidate should have worked as a site monitor in phase I to phase III clinical trials either in a CRO or a Pharmaceutical company in USA.

Knowledge and Skills (Functional / Technical)

• Excellent understanding of Clinical Pharmacokinetics and Phase I to Phase III Clinical Trial execution at US/ global sites, project management and monitoring.
• Hands-on experience in the management of Phase I and Clinical Pharmacology (TQTc Studies and DDI Studies) studies for Branded Generics and innovative (NBE/NCE) portfolios.
• Hands-on experience of managing FTIM studies
• Excellent understanding of GCP
• Substantial experience in project management (formal training in Project Management will be preferred)

Physical demands and abilities

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office
• Incumbent may encounter frequent interruptions throughout the work day.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve peoples’ lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

BENEFIT HIGHLIGHTS

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Corporate Discount Program
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Commuter Accounts
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.