Clinical Data Manager II

Company Description

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

Job Description

• This is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial

• May be a member of more than one project of low to moderate complexity or member of one project of high complexity

• This position makes recommendations and influences decisions for specific trials or assignments

• The Senior GDM influences processes, timing, and structure for specific trials or assignments

• This position analyzes, provides recommendations, and makes decisions with direction from manager or DML

• This position requires In-depth knowledge of the protocol

• In-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required

• This position needs to understand relevant system/technical knowledge

• Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required. 

Supervision Received:

• Work is received in broad terms

• Work is reviewed during major deliverables

• Amount of instruction is limited

• Work is reviewed with the Data Manager Leaders as well as with the immediate manager. 

Supervision Given:

• There are no direct reports for this position

• This position collaborates with Vendors/CROs to achieve successful, cooperative partnerships

• This position may delegate tasks and assignments to Global Data Managers

• The Senior GDM recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship. 

Qualifications

• BS/MS in science related field with relevant experience

• Experience with CDMS/EDMS system

• Working knowledge of contract and budget preparation and negotiations

• In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required

Additional Information

Thanks

Regards

Ricky