Site Activation Associate ; AES

Purpose:

Assists with the development of the critical path for site activation within assigned projects to provide consultation, guidance and support for rapid site activations.

Achieves established project target cycle times for site activations.

• Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members.

• May provide support or information for negotiation and finalizing site agreements, budgets and essential documents with study sites in accordance with local/accepted process.

• Complies with established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.

• May work directly with site to obtain documents related to site selection.

• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Assists with the preparation of the regulatory compliance review packages, as applicable. This may include working directly with sites.

• Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.

• May develop country or site specific documents.

• Provides support as needed to help with the coordination with internal functional departments to ensure site startup activities within the site activation critical path are aligned.

• Ensures that trial status information relating to activities are accurately maintained in the database and is current at all times.

Purpose:

Assists with the development of the critical path for site activation within assigned projects to provide consultation, guidance and support for rapid site activations.

Achieves established project target cycle times for site activations.

• Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members.

• May provide support or information for negotiation and finalizing site agreements, budgets and essential documents with study sites in accordance with local/accepted process.

• Complies with established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.

• May work directly with site to obtain documents related to site selection.

• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Assists with the preparation of the regulatory compliance review packages, as applicable. This may include working directly with sites.

• Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.

• May develop country or site specific documents.

• Provides support as needed to help with the coordination with internal functional departments to ensure site startup activities within the site activation critical path are aligned.

• Ensures that trial status information relating to activities are accurately maintained in the database and is current at all times.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills and Abilities:

• Effective oral and written communication skills

• Good interpersonal skills

• Capable of applying strong attention to detail to produce quality documentation

• Basic negotiation skills

• Basic computer skills and the ability to learn appropriate software

• Adequate English language and grammar skills

• Essential judgment and decision-making skills

• Basic medical/therapeutic area and medical terminology knowledge

• Excellent team player with team building skills

• Basic organizational and planning skills

• Capable of accurately following project work instructionsEducation and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills and Abilities:

• Effective oral and written communication skills

• Good interpersonal skills

• Capable of applying strong attention to detail to produce quality documentation

• Basic negotiation skills

• Basic computer skills and the ability to learn appropriate software

• Adequate English language and grammar skills

• Essential judgment and decision-making skills

• Basic medical/therapeutic area and medical terminology knowledge

• Excellent team player with team building skills

• Basic organizational and planning skills

• Capable of accurately following project work instructionsUS-New Jersey, US-Massachusetts, US-Maryland, US-Florida, US-Texas, US-North Carolina, US-California, US-ArizonaUS-New Jersey, US-Massachusetts, US-Maryland, US-Florida, US-Texas, US-North Carolina, US-California, US-Arizona