Manager/Sr Manager, Data Management

4 weeks ago


Cambridge, United States Innova Solutions Full time

Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data Management

Position type: Full Time Perm

Location: Preferred location Cambridge, MA / Remote

Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candidate

As a Manager/Sr Manager, Data Management you will:

RESPONSIBILITIES

Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team QC each deliverable prior to sending to internal or external clients Prepare and present individual performance reviews Provide mentorship to DM staff and suggest/implement solutions for complex issues Assist staff with interactions with sponsors and managing vendors Keep supervisor updated on study progress and staff management through routine meetings Maintain a positive, progressive, and proactive management style and communication Develop and update data management SOPs and training manuals Conduct data management training as well as study specific training for the CDM and study teams Provide input from the data management perspective regarding the design of clinical trial protocols Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures Oversee and participate in the process of data review and query generation procedures Oversee and participate in the coding of medical terms Oversee/define/perform SAE reconciliation processes Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system Ensure proper completion of UAT of EDC system and modules Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation Review queries and trends to ensure data completeness and integrity Review/prepare training materials and user guides for EDC data collection tools, deliver user training Participate in client and team meetings as required advising on best practices as appropriate Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes Implement technical solutions, new tools, and process improvement strategies Lead large and complex projects Identification of project scope changes Present at sales and marketing meetings for prospective clients Provide strategic input to the department and company goals Lead key departmental goals and initiative


EDUCATION

Minimum BS in a scientific or health related field or equivalent


EXPERIENCE

Minimum of 10 years of experience in Clinical Data Management Minimum 2 years supervisory experience is required


SKILLS

Knowledge of GCPs and regulatory agency guidelines Familiarity with medical terminology is required Skilled in the use of data management software application, Medidata RAVE Excellent organizational and time management skills Strong collaboration and leadership skills Excellent oral and written communication skills Strong interpersonal skills

Thank you

Preeti Sehgal

PAY RANGE AND BENEFITS:

Pay Range*: $175K - $185K depending on experience and level, might go up on the salary for the right candidate

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

One of Largest IT Consulting Staffing firms in the USA – Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS

Website

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.


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