Clinical Project Manager W2 ONLY

Recruiter
Consultant Specialists
Location
New York
Salary
Competitive
Posted
Sep 22, 2016
Closes
Oct 20, 2016
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Job Board
NYCityWorks.com


Job Description

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

W2 ONLY 2 Year Contract



Duties:

Provides global strategic direction and input for ensuring compliance to SDD to ensure our client meets 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 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

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.
  • 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

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)


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

Associated topics: clincial, clinic, clinical, coordinator, manager clinical, operations manager, project coordinator, project manager, research coordinator, study