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Sr. Clinical Data Manager - CNS, Diabetes, Pain

Apex Systems Boston Full-Time
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Senior Clinical Data Manager, CNS, Diabetes, Pain, 959608

Job Scope & Purpose:

If you are an experienced Sr. Clinical Data Manager, don’t miss this opportunity to work with a fabulous group of highly experienced leaders in CNS science!  Reporting to the Vice President Clinical Operations, the Senior Clinical Data Manager is responsible for overseeing and supporting data management at the CROs on multiple clinical trials and ensuring that data management objectives are met in accordance with clinical timelines, requirements and quality standards.  The Sr. CDM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues.

Primary Job Responsibilities:

  • Responsible for all aspects of the data management process from study start-up through database lock for individual protocols;
  • Act as the primary contact on all Data Management study-specific issues
  • Organize the data cleaning efforts with the internal study team and participate in data review
  • Act as internal consultant for clinical data management tools, standards and practices.
  • Contribute to the development and revision of relevant SOPs and internal processes
  • Formulate recommendations to Clinical Operations leadership on complex and important problems as they arise. 
  • Provide input regarding project resource requirements
  • Contributes to the development and continuing process improvement of relevant SOPs and internal processes

Primary Job Requirements:

  • Bachelors’ degree in scientific/clinical related discipline, Masters or equivalent preferred, with at least 5 years of relevant work experience in a pharmaceutical or biotechnology environment
  • Comprehensive knowledge of industry standards for data, including ICH guidelines, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
  • Familiarity with SAS as well as expertise in Medidata Rave or another modern EDC system
  • Proven track record of anticipating potential data management issues within a study and program and preparing contingency plans
  • Experience with the implementation of industry standards (CDISC, CDASH and SDTM)
  • Functions independently with minimal oversight and willing to “wear many hats”
  • Strong written and verbal communication, organizational and interpersonal/team skills
  • Proficient in MS Excel, Word and PowerPoint
  • Demonstrated experience with Electronic Data Capture (EDC)
  • Excellent time management skills, ability to organize and prioritize workload, attention to detail, and demonstrated ability to multi-task
  • Strong critical thinking and problem-solving skills

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

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Code: ClinOps

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

 

Skills required

Administration
Problem Solving
Training
Recruitment
Performance Management
Appointment Scheduling
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Job ID: 959608

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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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