Sr Project Manager Clinical Operations

Tech Observer (www.tech-observer.com),a global Clinical Research Organization (CRO) supporting the Pharmaceuticals & Life Sciences industry since 2005.

Our offices are located in New Jersey (Headquarters), India (Mumbai, Noida, Hyderabad, Ahmedabad), Denmark, UK, and Singapore. Through our local partners, we extend our coverage to Australia, China, Malaysia, South Korea, Taiwan, Thailand, Vietnam, and other countries.

Key Responsibilities (but not limited to)

• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.
• Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Arrange and participate in investigator meetings and liaise with vendors to facilitate the smooth conduct of the same.
• Identify and manage vendors in accordance with Tech Observer/ Sponsor SOP’s, GCP and Local Regulatory Guidelines for study specific deliverables (including but not limited to; Clinical Trial Management System, Study Equipment’s, Travel Arrangements, Couriers, etc.) in delegated projects.
• Develop study management plans and generate tools to facilitate tracking of performance at project level.
• Serve as primary point of contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
• Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties (Senior Management Tech-Observer/ Sponsor/ Data Management/ Medical Writing/ Stats, etc.).
• Liaise with study team and facilitate (if required) selection of Investigator/ site as well as assist in Contract development and setting up the Investigator payment procedures for designated studies. In absence of team members, ensure the Investigator/ site payments are processed as per the agreed timelines in the executed contract.
• Provide inputs for the development of proposals for new work and manage project budgets.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Prepare and present project information at internal and external meetings.
• Participate in proposal development and in the bid-defence process with guidance and supervision.
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.
• Recruitment, retention, training, appraisal and supervision of clinical trial team members.
• Ensure timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
• Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify issues of importance.
• Actively participates in site payment runs and basic understanding regarding data input into tracking systems and analysis of site payments with supervision.
• Based on Project requirements, act as Lead for on-site/ remote monitoring projects. Responsible to ensure that all the related activities delegated are conducted in compliance with Tech Observer/ Sponsor SOP’s, Monitoring Plan, GCP and Local Regulatory Guidelines.
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conformance to those requirements and co-ordinating any necessary audit processes.
• Liaise with the Trials Steering Committee; Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
• Work with the Lead Principal Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
• Ensure timely update of project deliverables to sponsor representatives and key stake holders.
• Organize and steer regular client update meetings and ensure timely provision of meeting minutes.
• Oversee the creation and maintenance of all trial files, including the trial master file, regulatory binder and Investigator site files.
• To oversee the activities of the Asst. Project Managers on periodic basis.
• Other responsibilities as delegated by the management representative.
• Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.