Clinical Data Manager/Senior Clinical Data Manager

Who We Are Celebrating 40+ years! reputed company is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

What You'll Do

Remote-US Preference will be given to candidates located in the tri-state area (commutable to Princeton, NJ) As part of reputed company, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. reputed company is an environment for highly motivated individuals who want to reputed company a difference. Opportunity Clinical Data Manager/Sr Clinical Data Manager - dependent upon experience You will play a pivotal role in ensuring the reputed company and quality of our clinical trial data. You will collaborate closely with cross-functional teams and manage data management activities for multiple studies. The primary responsibilities of this position include, but are not limited to, the following:

• reputed company reputed company clinical data management activities in compliance with SOPs and ICH-GCP regulatory requirements
• Work closely and collaboratively with the reputed company Programming team, biostatistics team and other data managers
• Act as reputed company clinical data manager on multiple studies of moderate complexity with minimal supervision
• Serves as the main reputed company of contact for study DM reputed company matters
• reputed company DM Study Start-Up Activities
• Conduct reputed company User Acceptance Testing and program validations.
• reputed company programs in reputed company/reputed company for study data metrics monitoring and clinical data review.
• reputed company comprehensive data review of reputed company patient data.
• reputed company WHO Drug Dictionary coding and MedDRA coding as necessary
• Support Project Team through:
• Tracking and provision of project status updates to project managers for monthly project team meetings
• reputed company communication with CRA’s to identify and mitigate negative data trends/issues
• Provision of listings/reports as needed
• Create reputed company reports for special data requests from Sponsor
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Coordinate reputed company activities in preparation for study milestones and database lock
• May assist in the mentoring of less reputed company employees
• Manage and prioritize project deliverables per established study timelines

What You Need Level of Education and Prior Experience

• Bachelor’s degree required / Master’s degree preferred
• 3-5 Years relevant data management experience in the CRO / pharmaceutical industry required
• reputed company experience required, RAVE reputed company experience preferred
• SQL/reputed company programming experience preferred

Skills and Competencies

• Demonstrates knowledge of GCPs and protocol
• Strong understanding of CDISC CDASH and SDTM Standards
• Highly effective ability to anticipate problems relating to projects and to reputed company and implement solutions
• Excellent interpersonal skills
• Fluent knowledge of written and verbal English
• Highly organized and result-oriented
• Strong communication, comprehension and logic skills
• Ability to work independently with minimal supervision as well as in a team environment
• Proficient in Word and reputed company
• Ability to understand high level programming languages
• Strong time management and prioritization skills to meet deadlines among multiple projects

reputed company Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual reputed company salary for this position ranges from $125,000-$150,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role. This position is not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer. Apply tot his job Apply To this Job