Senior/Principal Data Manager

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details

Senior/ Principal Data Manager

LOCATION - Onsite in Cambridge, MA

SALARY

$130,000 - $170,000 + benefits package

The Senior Clinical Data Manager provides oversight of program of studies, will provide clinical data management leadership to the study team, and will serve as primary point of contact for internal and external study team members. This role will be embedded at a large global pharma company.

ROLE/DESCRIPTION

  • Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
  • Provides strong quality and project oversight over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Lead or support the Health Authority inspections and audits
  • Provides coaching and quality oversight of junior Data Management Leads
  • Vendor management to EDC and CRO
  • PHRI & Elluminate platform experience is a PLUS

REQUIREMENTS

  • 10+ years experience as a clinical data manager
  • 3+ years experience independently leading studies
  • Must have technical / hands on experience with database build (ecrf design, edit checks, UAT)
  • Strong communication skills
  • Must be located in the US

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organizations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Liana Nobile by email at lnobile@i-pharmconsulting.com. If this role is not suitable, Liana is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
I-Pharm Consulting
I-Pharm Consulting

Current Openings: 0

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. We have specialist teams working from offices in London, Munich, Frankfurt, New York, Charlotte, San Diego and Sydney, focusing on the UK, European, U.S. and APAC regions. Driven by our mission of “changing lives by placing people at the heart of life sciences’, we provide tailor-made solutions to our global client base. We have specialised solely in life sciences from the start. By focusing on selected functional markets, we have built a deep understanding of the needs, opportunities, challenges and cultural nuances in each of our areas of specialism. Coupled with a thorough understanding of each client, and a global network of candidates nurtured over our thirteen years, this puts us in a unique position: we provide unrivalled insight, advice and support to ensure the right technical and cultural alignment, every time. We an source talent across a range of services, offering our clients flexible solutions to successfully deliver projects on time and on budget. - Permanent Recruitment - Contract Recruitment - Executive Search Operating in a complex and fast-changing industry sector, we understand the importance of specialist knowledge. We work across the Pharmaceutical, Biotech and MedTech sectors, with a particular focus on the following specialist areas. Drug Development - Clinical - Biometrics - Quality Assurance & Tech Ops - Regulatory Affairs - Commercial - Medical & Scientific MedTech - Commercial - Quality Assurance / Regulatory Affairs - Research & Development Life sciences has never played a more important role for society, and we’re determined to deliver even greater support in the years ahead.
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