Job Description :
Title : Project Analyst
Duration : 2 Years (24 Months)
Location : New York, NY

Description:
Provide day to day oversight and prioritize Project Analyst activities.
Serve as an escalation point for analyst''s activities to help address concerns and/or questions.
Provides global strategic direction and input for ensuring compliance to SDD to ensure current and future business needs.
In collaboration with GPO, Define and track key milestones and deliverables ensuring delivery on the strategy and tactics for SDD
Develop communication plan for SDD in conjunction with the global Process owner
Work with key internal and external partners to develop future strategies and through strong collaboration build and maintain communication networks with key external stakeholders
Effectively represent internal and external stakeholders on oversight committees (e.g. Steering Committees, Advisory Boards, QATs) and other cross-functional working groups to ensure that the SDD procedures remains in alignment with other global procedures.
Establish analytics and metrics to ensure SDD procedures will withstand regulatory scrutiny

Operational Support:
Supports the functions to ensure compliance SDD during the clinical trial
User Registration review
Transmission Support and correction
Arriving at close out
Manage Unblended distributions
CAR Governance
CAPA Management
Support study teams and affiliates in preparation for Inspections and audits
SME for questions on SDD during inspections
Conduct root cause analysis for all major and critical findings
CAPA Implementation lead role for SDD specific issues
Identify Affiliate Management training needs and develop/implement training strategies/interventions for their area of expertise in conjunction with internal and external functional and/or training groups and in alignment with other functions as required.
Develop and execute a quality control (QC) plan to determine if end user adoption and consistent implementation of processes and procedures for their area of expertise have been achieved.
Lead and/or participate in activities and knowledge sharing in their area of expertise to improve and maintain the quality of training and development.
Knowledge Management
Support Global Procedural documents and related process documents
Manage SDD wiki
Manage training strategy
SME for questions and primary point of contact for issue escalation

Acronym Definitions:
SDD - Safety Document Distribution
GCP – Good critical practices
GPO – Global Process Owner
CAR Governance – Country Alerting Rule Governance
CAPA Management – Corrective Action Preventative Action

Skills:
Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision.
Expert knowledge of ICH/GCP, EMA, Global procedural documents and local regulatory requirements.
Broad current knowledge of clinical development processes, roles and responsibilities
Strong, dynamic leadership or management experience (including study or project management) with consistent delivery against commitments and goals
Strategic and forward thinking, creative in solution development, independent decision making, prioritization, and managing multiple tasks abilities - able to make sound, timely decisions within areas of own responsibility and recognizes when and how other stakeholders need to be involved.
Communicates effectively with credibility and confidence to present clear messages from complex information/data to all levels in the organization.
Ability to influence a variety of stakeholders, external parties and colleagues, at a range of levels in the organization.
Able to choose and deploy a broad range of influencing strategies. Strong customer focus.
Leading Innovation & Change / Innovate, learn and change
Travel

Education:
Minimum of four (4) year University degree preferable Life Science field
Minimum of 5 years of experience with Global Operational teams and at least three (3) years Manager experience (preferred)

Thanks & Regards,
Swetha
Technical Recruiter
Zolon Tech