Skills

With over 11 years of rewarding experience, seeking challenging assignments across the Clinical Research industry in the area of Clinical Operations with varied exposure in other departments like Regulatory filling, project management, Quality assurance, late phase operations, Worked as a CRA, Sr.CRA, Project Head and Team Lead  presently working as Associate Manager, (eTMF) Regulatory environment and Records Management, Proficient in swiftly ramping up research projects with cross-functional skills & ensuring deliverables within stipulated time frame expertise in project planning, scheduling & resource planning to achieve specific research targets. Also give inputs and do the needful documentation for regulatory submission in consultation with the regulatory expertise. Hands on Experience on different therapeutic Areas/Indications of global and domestic Clinical studies like Gastroenterology, Endocrinology, Neurology, Oncology, Cardiology, Urology, Respiratory, Biologics, wound care management, infectious diseases and medical device trials and academically proficient with Masters in Pharmacy

CORE COMPETENCIES: Clinical Operations • End to End knowledge of clinical development • Quality-driven in all managed activities • Project Planning • Documentation in Clinical Trials •Project budgets • Team Management • Coordination & Negotiation Skills • Process Management/Development • Training & Development • eTMF Tools

Refrences

• Manage and oversee team activities including appropriate resourcing of staff, staff assignments and quality control of project deliverables and timely delivery of project deliverables.
• Monitor performance, close interaction with PL/GRO Lead
• Train, mentor and allocate team members according to their ability
• Provide technical support to team members to ensure that they have the required knowledge to fulfil their duties.
• Check quality of team deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action.
• Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team.
• Maintain an agreed level of productivity/billability and staff turnover.
• Participate in and contribute to Project bids, including client presentations.
• Meet client and business needs to have all projects optimally resourced with suitably experienced staff.
• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.
• Produce accurate resourcing plans in conjunction with the appropriate Project Team Members.
• Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget.
• Responsible for own assignments as project team member. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables.
• Responsible to coordinate client or account activities for department or function.
• Prepare and submit weekly study specific status reports to Project Team, Sponsors and management and attend project team meetings.
• Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports.
• Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
• Maintain a positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced and objective manner
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Company WSOPs.
• Participate in Company and department system/standards improvement activities.
• Support efforts for generating business leads (client networking, public speaking, etc.).
• Complete routine administrative tasks in a timely manner as per department requirement

Managing and mentoring the team of 15-20 members in vertical level and project level by conducting team huddles and sharing. Creating and sustaining a dynamic environment that fosters development and motivates high performance amongst team members.

Get In Touch