Celgene IIT Associate Manager, Medical Affairs in Sweden, AlbertaSweden

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture

Summary

The IIT associate manager, medical affairs is responsible for supporting the generation of data through investigator initiated research studies that are in line with the local and global strategy. This individual is responsible to support the IIT managers as well as RMLs in all activities linked to Nordic investigator initiated trials (IIT´s) and global research grants (GRG). He/she ensures appropriate support, in cooperation with IIT managers, to investigator/sponsor of the trials leading to the performance of trials in accordance with the Celgene Europe IIT and global research grants working procedures and SOPs as appropriate. In addition, he/she is responsible for the drug supply of an investigational site.

Main responsibilities will include, but are not limited to:

Responsible regarding the following items in investigator initiated trials (IIT) in the Nordics including:

  • Ensure review and assessment ofIIT proposals (in line with local and global strategy)

  • IRC preparation

  • Arrange review of protocol and PIC(in line with approved proposal and safety requirements)

  • Arrange for contract includingnegotiations. Within this scope the individual liaises with the EU IIT managerand legal department of HQ.

  • Follow up on invoices and payments

  • Arrange clinical trial supplies inclose cooperation with the EU IIT manager and drug supply departmentresponsible.

  • Administration and coordination ofIIT's including:

  • Update of clinical databases

  • Works closely together with theregulatory department in the Nordics to ensure the sponsor/investigator meetsall rules and regulations (CTA, IMPD etc.)

  • Work closely together with thesafety department in the Nordic to support the sponsor/investigator to meet allsafety requirements

  • Ensure that publications relatedto IITs are submitted for approval to Celgene in accordance with the agreementclosed between Celgene and the investigator.

  • Liaise with and participate ineducation of RMLs for support of the IIT’s during all stages of the trial.

  • Liaise with IIT manager inappropriate matters.

Responsible for administrative support to RMLs regarding global research grants (GRG) in the Nordic region

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Qualifications

  • Medicalor scientific education or experience from similar positions

  • Minimum5 years of experience in clinical studies

Skills/KnowledgeRequired:

  • Documentedtrack record in clinical operations department of local affiliate

  • Fluentin English (written and verbal)

  • Willingnessto develop regulatory, pharmacovigilance and IT items related to IITs and GRGs

Competencies

  • Demonstratesadvanced communication and presentation skills

  • Demonstratesstrong project management

  • Displaysstrong organisational and time management skills; multi-tasks effectively;serves as a role model for completing tasks and delivering on commitments in atimely manner

  • Demonstratesa strong customer orientation; is science- based and marketing-minded

IIT Associate Manager, Medical Affairs

Location: Sweden, AB, SE

Job ID: 17001846