Clinical Project Manager W2 ONLY

Consultant Specialists
New York
Oct 01, 2016
Oct 29, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Job Board

**Local NY Candidates Preferred; No Relocation Available**

W2 ONLY 2 Year Contract


Provides global strategic direction and input for ensuring compliance to SDD to ensure our client meets current and future businessneeds.
  • 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 Unblinded 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.
  • Ensure our client is inspection ready related to SDD procedures

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

  • 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.
  • Significant experience in clinical operations, drug safety or regulatory. {REMOVE for SOQS staff}
  • 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

  • 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)


SDD - Safety Document Distribution

GCP Good critical practices

GPO Global Process Owner

CAR Governance Country Alerting Rule Governance

CAPA Management Corrective Action Preventative Action

Associated topics: clincial, clinical, coord, coordinator, manager clinical, operations manager, project coordinator, project manager, research coordinator, trials