Associate Director Data Management - Clinical Trials
Location: Edinburgh, Scotland GB
Job Id: 3022
Position Title: Associate Director, Data Management
You will manage the day-to-day activities of the Data Management function in accordance with Standard Operating Procedures (SOPs), regulatory directives; and study specific plans with an emphasis on effective resourcing and development of the team.
Why should you consider joining us?
Because we are not your typical CRO. As a member of our growing team, we have great opportunities for you to work with leading subject matter experts, who understand the oncology and rare disease patient mindset. We help translate science into success for oncology and rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community.
- You work independently successfully and have established credibility to make decisions with minimal direction
- You have excellent attention to detail, documentation skills, and work well in a group environment
- You are a flexible, agile and able to successfully change activities and directions quickly when responding to changing business needs
- You are approachable, have an open and transparent communication style positioning you to gain the trust of others
- You are passionate about inspiring those around you leading to dedication to meet team and company goals.
If this summarises you, we are ready to receive your application now.
A glimpse of what your day-to-day may look like:
- You will provide oversight for data management projects;
- Coordinates inter-departmental and client communication and helps resolve administrative, personnel, and site issues.
- You will be responsible for cross functional standardization and harmonization, technology and process improvement and resource and business forecasting.
- You will collaborate with executive management on the ongoing development of the Data Management function, and facilitates certain initiatives/special projects such as department level training, software and/or systems analysis or implementation.
- You may be required to do some travel.
Minimum Required: Bachelors degree and/or a combination of related experience
- 10 years or more experience in data management in either a CRO/or pharmaceutical or biotech industry or equivalent relevant experience and or demonstrated competencies
- Strong leadership and interpersonal skills
- Significant management experience, in leading, training and mentoring team.
- Proficiency in Microsoft Office
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Fluency in English and for non-English speaking countries the local language of country where position based
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Ability to undertake travel domestically and internationally with overnight stays
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
- Experience in clinical data management system design and development
- Oncology and/or Orphan Drug therapeutic experience
- Experience in business development and producing cost estimates
- Experience in vendor management
Precision for Medicine Oncology & Rare Disease is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Edinburgh - 63A George Street, 3rd Floor, Edinburgh, UK, EH2 2JG
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: No
Country: United Kingdom
Community / Marketing Title: Associate Director Data Management - Clinical Trials
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC
Location_formattedLocationLong: Edinburgh, Scotland GB