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AstraZeneca | Hiring | Associate Director Clinical Data Management | BigDataKB.com | 2022-09-09

Job Location: Bangalore

JOB TITLE : ASSOCIATE DIRECTOR


CAREER LEVEL: E

Embrace novel and varied challenges working across the business

Be connected to different functions, areas and roles across the business. We are supported by leaders in our aspiration to break down boundaries and draw on inter-functional learnings. It means we get to face interesting business problems and varied data. One day working along the whole development cycle from molecules to delivery, the next supporting HR processes or medicine launches


About astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.


About the team

A team of deep specialists, our skills range from mathematics to computation. Our diversity is our strength. We turn complex information into lifechanging and practical insights, every day. Our progressive operating model means that we stay at the forefront. Evolving and learning from what we’re seeing externally. We impact patient’s lives. Empowering and enabling the business to run faster and better, we play a part in improving lives across the world


About the role


Job Description / Capsule

Acts as a team leader and provides training or coaching to junior colleagues within CDM. Responsible for the oversight of the Clinical Data Management (CDM) delivery of high-quality data via external partners or internally run studies for one or more assigned projects or an indication. Maintains an up-to-date awareness of trends/changes in external CDM approaches and serves as a subject matter expert in process development and improvement.


Typical Accountabilities

  • Acts as a team leader and provides training or coaching to junior colleagues within CDM

  • Performs line management responsibilities such as performance appraisals and mentoring

  • Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.

  • Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance. Provides CDM leadership for assigned projects, indications and/or studies dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level.

  • Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies.

  • Communicates and negotiates effectively with all other project level team members. Primary point of contact for Clinical Data Management (CDM) at the Global Program Team (GPT) level.

  • Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned projects, (i.e. ensuring consistency across data quality plans.)

  • Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on AZ standards, processes, systems and expectations to external partners, internal partners and third-party vendors.

  • Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.

  • Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.

  • Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate

  • Provides data management expertise in supporting strategic and operational aspects of Data Management on project level..

  • Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.

  • Performs any CDM related ad-hoc requests from Line Manager or other senior managers


Education, Qualifications, Skills and Experience


Essential

  • University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.

  • Ability to successfully manage simultaneous trials and meet deadlines.

  • Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area.

  • Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.

  • Comprehensive knowledge of clinical standards, e.g. SDTM or CDASH.

  • High attention to detail and a strong analytical mind-set.

  • Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.

  • Excellent interpersonal skills and proven ability to operate effectively in a global environment

  • Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.

  • Cultural awareness.

  • Experience of CRO and vendor management.


Desirable

  • Experience as a lead of a large Phase III trial or multiple smaller trials;

  • Knowledge of SQL, 4GL, VBA or R software

  • Experience of managing teams.


WHY JOIN US ?

A place to do important work. We connect across the whole business to power each function to better influence patient outcomes and improve their lives. Impactful and valuable, this is where you come to raise your profile and do good for others. Rise to the challenge of shaping the future of an evolving business in the technology space.


SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.


WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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