Senior Data Manager

  • Location
    Whippany, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Information Technology - Business Analyst

Adecco is currently assisting a local client in their search to fill an exciting Senior Data Manager role in Whippany, NJ! Apply now if you meet the qualifications listed below!



***Applicants must be currently authorized to work in the United States on a full-time basis. This employer will not sponsor applicants with the following work visas:
H1B, H2B, E3, TN1***

please feel free to reach out to: Matthew Greene at Matthew.Greene@adeccona.com




POSITION: Senior Data Manager
LOCATION: Whippany, NJ 07981 (No Remote Work - Must be onsite in Whippany, NJ. (No per diem, no travel reimbursements, or other expenses offered)


START DATE: ASAP
DURATION: one year
PAY RATE: Adecco W2 all-inclusive hourly rate / Dependant on qualifications and experience


DEPARTMENT/TEAM DESCRIPTION
Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities. Contributions
include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.

POSITION SUMMARY
Tasks
- Governs use of key data management elements across studies in assigned project: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility (GMSIT AS/CPS/Codelists); provides data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules.
- Ensures adequate application of Data Management Best Practices across studies within assigned project: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.
- Provides oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing , synergies, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices.
- Advises on resource planning/allocation based on forecasted activities per the Medical Affairs Plan and actual study/project metrics.

Implementing Strategy
- Supports the development and implementation of Project and Study Data Management strategic initiatives and activities.
- Contributes to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management.

Ensuring Compliance
- Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (Ols) and Process Guidance Documents (PGDs)

REQUIREMENTS/PREFERENCES Education Requirement(s):
• Bachelor's Degree required
• Master's Degree preferred

Skill & Competency Requirements: (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)
• At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles.
• At least 2 years of experience should demonstrate responsibility as the DM lead on studies/project(s).
• Deep understanding of the drug development process. Strong organizational skills and able to • collaborate with minimal supervision.
• Significant experience of using data management methodologies and technologies (e.g. data warehousing, electronic data capture).
• Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical TrialsDirective, Privacy rules (HIPPA).

Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
• Basic SAS Programming knowledge, or other database experience, preferred.




IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities available at Adecco go to www.adeccousa.com.



***Applicants must be currently authorized to work in the United States on a full-time basis. This employer will not sponsor applicants with the following work visas:
H1B, H2B, E3, TN1***

please feel free to reach out to: Matthew Greene at Matthew.Greene@adeccona.com



The Adecco Group is a global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k) and Insurance Benefit Plans.
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Reference number US_EN_2_022862_404652