Senior Data Manager Consultant

ClinChoice; Horsham (PA); On-site; USD 90,000 - 150,000; Full time

Job summary

ClinChoice is seeking a Senior Data Manager Consultant in Horsham, PA for a client-focused, global CRO environment. You will lead DM activities, manage timelines, and collaborate with cross-functional teams to deliver high-quality data for clinical trials.

The role requires strong knowledge of eCRF systems (Medidata Rave, InForm, OpenClinica, Medrio) and expertise in DM plans, QA, and regulatory guidelines. Excellent communication is essential.

Qualifications

• Bachelor's degree or higher in clinical/pharmacy biology or related science.
• At least 3 years of data management or related experience in pharma.
• Knowledge of clinical trial processes and regulatory terminology.

Responsibilities

• Lead data management activities and ensure study deliverables meet timelines and quality standards.
• Review clinical research documents such as protocols and Case Report Forms.
• Create and review eCRF specifications.
• Develop DM documents: Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
• Provide training to the clinical team and sites.
• Perform data review/reconciliation and provide metrics for data clean-up.
• Coordinate archiving of study databases and related documents.
• Create Data Transfer Specifications and perform external vendor reconciliation.
• Perform SAE reconciliation.
• Maintain/improve client satisfaction through high-quality service and communication.

Skills

Data management

Clinical data

eCRF concepts

GCP/ICH knowledge

SOP compliance

Communication

Documentation

Education

Bachelor's degree in clinical/pharmacy biological/mathematical sciences or related field

Nursing degree

Tools

Medidata Rave

Oracle InForm

OpenClinica

Medrio

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for an Senior Data Manager Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.

The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and close-out. The Data manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key responsibilities may include, but are not limited to:

• Lead Data management activities and ensure study deliverables meet timelines and quality standards.
• Review of Clinical research documents (e.g. protocols, Case Report Forms).
• Create and review electronic Case Report Form (eCRF) specifications.
• Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan. Develop edit rules/checks, query logic and query messages.
• Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
• Create and provide training to the clinical team and sites.
• Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
• Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
• Coordinate the archiving of study databases and related documents
• Create Data Transfer Specifications and perform external vendor reconciliation.
• Perform SAE reconciliation.
• Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.

Qualification

• Bachelor's degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
• Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
• Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
• Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
• Perform duties in compliance with SOPs, GCP and ICH guidelines.
• Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
• Ability to lead a study or data management team independently.
• Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
• Excellent verbal and written communication skills.
• Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.