Associate Director/Senior Manager, Data Management - San Diego, CA | Biospace
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Associate Director/Senior Manager, Data Management

Heron Therapeutics

Location:
San Diego, CA
Posted Date:
9/19/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

At Heron, our mission is to improve the lives of patients by developing best-in-class medicines that address unmet medical needs.  We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents.

If you are looking for a career in a company that's evolving, has a great culture and amazing opportunities within the Biotech Industry, Heron is the clear choice.  As part of the Heron team, you will work with motivated team members who have pride in - and passion for - what they do.  Guided by our core values, we remain steadfast to our commitment to career growth and development for all levels of team members.

We are looking to add the position of Associate Director/Senior Manager, Data Management to our collaborative and entrepreneurial team who share our passion for helping patients.

About the Job

The Associate Director/Sr. Manager, Data Management will be responsible for supporting the planning, oversight and implementation of data collection, cleaning, and locking for clinical trials of multiple products conducted by Heron. The incumbent will provide support on the development of documents for clinical research studies, including protocols, case report forms, etc. to ensure consistency within the program and will provide CRO oversite to ensure the quality of all deliverables. May also supervise one or more full-time or contract data managers.

What You'll Do:
• Provide data management support to all Heron projects (Phase 1 to 4)
• Manage data management  CROs
• Manage full-time and contract data managers
• Oversee, review and approve all data management documentation
• Ensure consistency across documentation in similar studies within a program
• Technical oversight of contracts supporting clinical trial data activities.
• Assist in the development of a comprehensive approach to coordination, harmonization and oversight of data management activities.
• Provide project management expertise, as needed, to insure quality and timely completion of project milestones.
• Participate in Clinical Project Teams

Requirements

• Bachelor’s Degree or higher.
• Minimum of 6 years of experience in leading and supporting data management in clinical research (at various levels and in different capacities), including academic and/or industry experience in all phases of clinical research, supporting US as well as international trials.
• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience.
• Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
• Knowledge of all aspects of clinical drug development (Phase 1-4).
• Ability to analyze information, review reports and prioritize actions.
• Excellent computer skills; strong verbal and written communication skills.
• Experience with US, EU, AP and international clinical research carried-out in developing countries.
• Ability to work well in a team environment both as a leader and a contributor.
• Open, engaging, and transparent work style.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures.
• Experience implementing data management requirements in an international setting, providing training and overseeing clinical research studies are all desirable.
• Ability to competently manage multiple competing priorities, switching priorities quickly as needs change. Must be comfortable working in a quick-paced environment.
• Demonstrated very high level of technical skill and expertise as pertains to data management for support and development.
• Demonstrated high proficiency in project planning and management and proactively anticipate and identify complex issues and problems.
• Demonstrated exceptional interpersonal skills and written and verbal communication abilities.
• Demonstrated excellent decision-making abilities with competency in making decisions and resolving problems. Ability to recognize which decisions may have a consequential effect on the Project and/or Study and to make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
• Demonstrated fluency in written and spoken English.
• Demonstrated ability to manage people and teams.
• Experience with Oracle Inform, Endpoint IRT and eCaselink highly desired.
• Ability and willingness to travel 10-25% of the time (internationally and domestically).

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.

EOE

Compensation, Perks & Benefits:

The Heron team works in a fast-paced, challenging, and rewarding environment, while enjoying regularly scheduled corporate events, a casual and flexible atmosphere, and excellent benefits, which include:

• Competitive Compensation with Bonus Potential
• Full Health Benefits - Medical/Dental/Vision
• 401k, Flexible Spending, Employee Stock Purchase Plan
• Paid Time Off, Sick Pay and Tuition Reimbursement

As an equal opportunity employer, Heron Therapeutics, Inc., is committed to a diverse workforce.  If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Heron Therapeutics, Inc. career website as a result of your disability.  You may request reasonable accommodations by calling 858-251-4400.