Overview
Skills
Job Details
Mandatory Skills Program Mgt., Clinical project mgt., Regulatory & Compliance, Bus. Process-Life Sciences, CTMS, PMP
Job Description JOB RESPONSIBILITIES-
Plan and manage delivery of the team s line-up of data science products as well as custom analytical projects for Life Sciences customers, ensuring that deadlines and requirements are met.
Thoroughly understand client's business needs and translate them into technical and analytical requirements.
Prioritize the requirements and clearly communicate them to team members.
Work with the data scientists and engineers to draft requirements, statements of work, budget estimates, scope definitions, timelines, risk mitigation plans and supplier line-ups.
Develop and manage project reports, plans, milestones, risks, issues, dependencies, resourcing, communications, legal, and financial issues.
Team Coordination: Collaborate with cross-functional teams including clinical operations, data management, regulatory affairs, and medical affairs.
Regulatory Compliance: Ensure clinical trials are conducted in accordance with clinical trial protocols, ethical guidelines, and regulatory requirements.
Risk Management: Identify and manage risks and issues that may impact the successful completion of clinical projects.
Prioritize work for internal teams; provide direction for junior team members to achieve client goals.
Perform and supervise routing and approval process for deliverables.
Set up tools and processes to facilitate communication and collaboration between team members.
Work with internal and external clients on identifying unresolved business needs to guide the team s product strategy.
Develop scalable, repeatable processes and suggest additional enhancements to drive efficiency for future customers and project teams.
Build relationships with internal and external partners.
May mentor junior team members.
QUALIFICATION REQUIREMENTS - Degree (BSBA) in any related field.
Experience: Strong experience in clinical project management or a related field.
Technical Skills: Proficiency in project management software and tools, understanding of clinical trial processes and regulatory requirements.
Expert knowledge of project management tools and best practices.
PMP certification is a plus.
Understanding of how data science models are developed. Clear, precise communication of complex concepts to lay audiences.
Strong motivation for self-guided learning with strong attention to detail.
(1.) To oversee quality assurance processes, ensuring adherence to coding standards , implementation of best practices and perform Value creation and KM activities.
(2.) To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.
(3.) Responsible for shaping the overall project strategy working closely with stakeholders to define project scope, objectives, deliverables and keeping track of schedule to ensure on time delivery as per the defined quality standards.