Search Jobs

Filter
Electrical Engineer (2)
Mechanical Inspector (2)
1st Shift Manager (1)
2nd Shift Area Manager (1)
Accounts Payable Specialist (PERM) (1)
Advertising Specialist - 10457035 (1)
Application Project Manager (1)
Applications Analyst (PERM) (1)
Associate Process Engineer (PERM) (1)
Azure Infrastructure Administrator - 11095763 (1)
Bilingual Area Production Lead (1st and 2nd Shift Openings - multiple) (1)
Biosample Associate - 10587481 (1)
Buyer (1)
cGMP Manufacturing Associate (1)
Clinical Documentation Manager - 10463000 (1)
Clinical Lab Scientist - Valencia, CA - in FG (1)
Cloud Tools Engineer - R1010415.01 (1)
Coding Specialist (1)
Contract Recruiter - 11098377 (1)
Contracts Administrator (1)
Controls & Instrumentation Technician (1)
Controls Systems Engineer II (PERM) (1)
Copywriter (1)
Corporate Communications - Senior PR Manager - 11073224 (1)
Credit & Collections Analyst (2 openings) - 11208578 (1)
Customer Success Manager (PERM) (1)
Desktop Support Analyst L2 (CONTRACT) (1)
Digital Marketing Consultant Director (PERM) (1)
Director of Programs, Industrial and Consumer Electronics (1)
Director of Quality (PERM) (1)
Drafting Technician (1)
Electrical Department Manager (1)
Electrical Department Manager (PERM) (1)
Electrical EIT (PERM) (1)
Electrical Engineer (PERM) (1)
Electrical Manufacturing Engineer (PERM) (1)
Electrician (1)
Employer Brand Leader - 11175672 (1)
Field Service Commissioning Engineer (PERM) (1)
GMP Cleaning Technicians (PERM) (1)
Head of Lab Animal Sciences/Attending Vet (1)
IT Networking Consultant (1)
IT Project Engineer (3 Month Contract - Possible Temp-To-Perm) (1)
IT Solutions Architect - Valencia, CA - 935 & 936 (1)
Java Software Engineer (1)
Jr. Desktop Support Specialists - Valencia, CA - 905,906 (1)
Licensed Clinical Laboratory Scientist - Valencia, CA - in FG (1)
Maintenance Mechanic (1)
Maintenance Technician (1)
Manufacturing Process Engineer (1)
Manufacturing Team Leader (1)
Manufacturing Technician (1)
Marketing Project Specialist II - 11087418 (1)
Marketing Services Production Designer - 11066494 (1)
Mortgage Processor Residential (CONTRACT) (1)
North American Channel Manager (1)
Nurse Professionals (CONTRACT) (1)
Office 365 / Azure Sr. Support Representative (PERM) (1)
Outside Sales Rep - Alabama (1)
Outside Sales Rep - NJ/PA (1)
PCB Manufacturing Engineer (1)
Plant Manager (1)
Plumbing Designer (PERM) (1)
Principal Automation Engineer - 11071299 (1)
Principal C/C++ Software Engineer (1)
Procurement Specialist - Valencia, CA - in FG (1)
Production Planners (Coordinators) - Valencia, CA - in FG (1)
Project Manager, Information Governance Program, Legal Operations - 11058749 (1)
Purchasing and Supply Chain Manager (PERM) (1)
Quality Control Technician II (Temp-To-Perm) (1)
Quality Control, Chemistry, 2nd Shift (1)
Quality Engineers - Valencia, CA - in FG (1)
Quality Specialist II (1)
Restructuring Bankruptcy Paralegal (PERM) (1)
Sales Effectiveness Project Manager - 11215670 (1)
Sales Manager (1)
Senior Accountant (1)
Senior Administrative Lead, Coding (Temp-To-Perm) (1)
Senior Controls Automation Engineer (PERM) (1)
Senior EDC Programmer - 11180653 (1)
Senior Electrical Designer (PERM) (1)
Senior Electrical Engineer (1)
Senior Electrical Engineer (PERM) (1)
Senior Engineer, QA Validation (1)
Senior HPC Computing Application Associate (PERM) (1)
Senior HPC Systems Administrator (PERM) (1)
Senior Laser Welder (1)
Senior Manager, ED Billing (Temp-To-Perm) (1)
Senior Manager, EDI (Perm) (1)
Senior Mechanical Engineer (PERM) (1)
Senior Product Manager - SaaS (PERM) (1)
Senior Project Manager (1)
Senior Sales Representative: Laboratory (PERM) (1)
Senior Structural Engineer (PERM) (1)
Senior Technical Writer - 11182391 (1)
Software Engineer - Development Engineering (Perm) (1)
Software Engineer III (PERM) (1)
Software Engineer in Test - 11165797 (1)
Software Product Manager (1)
Specimen Processors - Valencia, CA - in FG (1)
Sr Production Planner - Valencia, CA - in FG (1)
Sr Software Engineer (1)
Sr Systems Administrator (x2) (1)
Sr. Clinical Outsourcing Manager - 10947894 (1)
Sr. DevOps Engineer (PERM) (1)
Sr. Embedded Systems Engineer (1)
Sr. Manager of Quality Assurance (1)
Sr. Planner - Shelton, CT - 677 (1)
Staffing Production Coordinator (Temp-To-Perm) (1)
Support Desk Support Specialist (PERM) (1)
Systems Engineer (1)
Systems Test Technician - 10612880 (1)
Technical Operations Specialist (PERM) (1)
Technical Support Engineer (1)
Technical Support Engineer (Field Service - Digital Radiography) (1)
Technical Writer - Shelton. CT - 740 (1)
Telecom Planning Engineer (1)
User Support Specialist (Temp-To-Perm) (1)
User Test Specialist, Customer Support - 10598466 (1)
Validation Engineer III (1)
Validation Specialist - West Point, PA - 746 (1)
VP Business Development - Pharma and Drug Delivery (1)
Share:
« Return to Jobs
11444
Contract

Clinical Documentation Manager - 10463000

Location: San Francisco, California

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Clinical Documentation Manager

Hiring Organization: Connexion Systems & Engineering

Our client is seeking: Clinical Documentation Manager

Duties: Implements cross-functional business processes, and manages systems to ensure the highest level of quality is maintained and continuous improvement processes are applied. Creates and Manages TMF structure and repositories for clinical studies based on the Company standards. Facilitates the creation and implementation of necessary SOP and/or process changes and ensures inspection readiness.

Compensation, Benefits, and Employment Type

  • Duration – Contract
  • Pay rate:  65-69/hr.
  • Job Location:  Sunnyvale, CA
  • Job# bh11444
  • Date Posted: 6/10/2020

Assists in access and organization of the controlled clinical document storage on-site, including ensuring the defined file structure is maintained. Assists in the exchange of TMF documents with external service providers. Supports clinical trial managers and other relevant contributors to ensure ongoing content management of TMF. Perform periodic reviews of Trial Master Files to ensure adherence to standards and compliance with relevant regulations and guidelines. Provides assistance during internal/external audits of the TMF. Works with Management and the TMF team to insure that TMF is able to fully reconstruct the conduct of a clinical trial and that documents are readily available for audits/inspections.

Assists in the document preparation room during regulatory inspections. Assists in retention and destruction schedules for TMFs. Assists in off-site archiving activities (including budget, cataloguing process, and document retrieval). Assists in document index to ensure all on-site and off-site documents can easily be retrieved. Maintains knowledge of industry standards to ensure adequacy of the TMF system and continuous process improvement. Ensure CVs and JDs for clinical R&D personnel are maintained in the electronic training system to support inspection-readiness initiatives. Run periodic reports to evaluate training compliance and provide summaries to management. Assist study teams in ensuring that team members, vendors and investigative site training in GCP and other compliance requirements is properly documented Standard Operating Procedures. Participate in development and/or revision SOPs to ensure they remain current and reflect regulatory and business requirements. Perform initial and/or in-process assessment (on-site or remotely, when available & appropriate) of vendors standard operating procedures, and documents the review

Skills: As requested, provides quality control reviews of TMF related documents. Review documents across a given development program for consistency (e.g., monitoring and data management plans compared with the protocol or SOPs)

Review sampling of relevant study documents (e.g. monitoring reports, monitoring plans, data review plans) to assure adequate management of quality standards and risks are being employed

Collates, reviews and assesses with Management metrics (i.e., risk, quality defects, speed, cost) by which each process will be assessed and implements measures to improve processes or intervene as needed. Communicates critical issues, accomplishments, risks and modifications of current procedures to Management. Actively gathers and maintains knowledge on external industry best practices to ensure system are in keeping with industry standard. Responsible for the performance management and development of Document Specialists. Other duties as required.

Keywords:

Education: Bachelors’ degree is required. Equivalent experience may be accepted. A minimum of 8 years Pharmaceutical biotechnology or medical device industry is required with at least 3 years’ experience in Clinical Trial Master File management is required. Knowledge with Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, and FDA Code of Federal Regulations for clinical trials. Knowledge of global regulatory requirements and ICH/GCP guidelines. Knowledge of clinical research study design and ability answer technical questions related to tips, techniques and problem solving around TMF. Knowledge of eTMF systems preferred, specific knowledge of Veeva Vault eTMF processes is huge plus. Highly proficient with software capabilities and business applications Hands-on managerial/leadership experience required. Experience in management of multiple global clinical trial programs is highly desired. Experienced in handling trial essential documents and performing site monitoring required. Track record of delivering process improvement projects.

Possesses demonstrated ability to supervise others, either directly or in a project matrix scenario.

Strong interpersonal skills with a demonstrated ability to interact and influence with many levels of technical and business staff. Excellent analytical, problem solving and organizational skills are required.

Ability to establish excellent internal and external relationships; including vendors.

High level of flexibility and ability to adapt to changing conditions.

Good oral and written communication and interpersonal skills.

Skills and Experience:

Required Skills:

DOCUMENT MANAGEMENT


Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

 

*MON