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Clinical Data Solutions Manager

Company:
Ronan HR Solutions
Location:
Cambridge, Massachusetts, United States
Posted:
March 15, 2019

Description:

Responsible for timely and high quality data management deliverables supporting the portfolio.

Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards.

Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet obligations described in ICH-GCP and business objectives. Activities include from protocol synopsis through database release and submission

Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices.

Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making.

Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards.

POSITION ACCOUNTABILITIES:

Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations with the CRO for all data related deliverables, especially in support of key decision points and regulatory submissions.

Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.

Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.

Acts as a process expert for operational and oversight models.

Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.

May prepare metrics to support the function’s KPIs.

Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.

Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documents

Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting.

Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.

Other duties as assigned

Kindly submit your resume for immediate consideration

EDUCATION, EXPERIENCE AND SKILLS:

BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience.

Proven track record of strong project management skills and experience managing data management activities for large drug development programs

Experience with all phases of development and at least 2 therapeutic areas.

Ability to handle multiple development programs simultaneously.

NDA/CTD Experience.

Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.

Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.

Good understanding of CDISC standards, and experience implementing standards.

Strong knowledge of clinical study reporting requirements including SAS programming.

Advanced knowledge of office software (Microsoft Office).

Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.

Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.

Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

Demonstrated strong matrix leadership and communication skills

Able to influence without authority

TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other sites, strategic partners, and therapeutic area required travel.

WHAT WE CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan

Tuition reimbursement

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs