Mission

ClinicalResearchAssociateManagerSMM

$138–207k United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Clinical Research Associate Manager SMM at Mission. Skills: Clinical trial management, Line management, Performance management. Manage Clinical Research Associates. Execute clinical trials”

Industry & Context.

Problems you'll solve

Problem resolution; Escalation; Support for resolution

Eligibility Requirements

15% travel

What They're Looking For.

Must Have

8 years clinical trial experience, 4 years site monitoring, Fluent English, ICH/GCP knowledge, Local regulations knowledge, Medical knowledge in AZ Therapeutic Areas, Basic drug development process understanding, Clinical study management understanding, Monitoring understanding, Study drug handling understanding, Data management understanding

Nice to Have

Study leadership preferred, Line management preferred, Basic GMP/GDP knowledge, 15% travel required

What You'll Do.

Manage Clinical Research Associates

Execute clinical trials

Oversee project assignments

Resolve problems with direct reports

Interact with team management

Manage staff performance

Provide routine feedback

Provide feedback on contract staff performance

Project resource needs

Implement clinical studies

Ensure CRA allocation

Maintain working relationships

Ensure compliant monitoring

Ensure site management

Conduct quality visits

Communicate program changes

Communicate policy changes

Communicate priority shifts

Address staff workload issues

Escalate issues for resolution

Approve expense reports

Conduct staff meetings

Participate in management meetings

Lead special initiatives

Develop AZ relationship with sites

Mentor new team members

Ensure compliance with ICH/GCP

Ensure compliance with AZ Procedural documents

Contribute to process improvements

How You'll Work.

Team & Collaboration

Interact with team management; Work with other CRA managers; Work with Clinical Research Managers; Collaborate with colleagues; Work with US leadership team; Partner with operational sites; Work with local Study Delivery Team

Process & Methodology

Clinical trial management, Resource allocation, Timeline adherence, Workload distribution

Full Job Description

Role: Clinical Research Associate Manager SMM Type: Field - USA Direct functional line management of a group of Clinical Research Associates within US Site Management and Monitoring. Accountable for the successful execution of clinical trials including resource allocation, adherence to timelines and compliance with all SOPs, policies and regulatory requirements. Oversees project assignments, workload distribution and problem resolution with direct reports. Interacts with other team management and functions as needed. **Typical Accountabilities** * Responsible for performance management and development including talent development, coaching, mentoring and providing routine feedback. * Interviews, hires, develops and trains staff on AZ SOPs, policies and procedures. * Communicates regularly with contract staff managers to provide feedback on contract staff performance. * Evaluates and projects resource needs on an on-going basis based on portfolio. * Ensures the implementation of clinical studies through efficient allocation of CRAs. * Ensures close working relationship within US SMM including other CRA managers and Clinical Research Managers as well as other key internal/external stakeholders. * Responsible for ensuring adequate, timely and compliant monitoring, site management and oversight for assigned CRAs. * Conduct regular (twice annually) quality visits with each employee CRA. * Communicate with staff on program changes, policy changes, and priority shifts on a regular basis. * Be aware of issues affecting staff’s workload and efficiency. Collaborate with colleagues and US leadership team as needed for escalation and support for resolution. * Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies. * Conduct regular staff meetings and participate in Management staff meetings. * Leads special initiatives as needed. * Partner with key operational sites to develop/enhance AZ relati

Free ATS check

Applying for this Clinical Research Associate Manager SMM role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Workday

  • Workday has a multi-step form — save your progress after every section.
  • "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
  • Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
  • Job requisition numbers are useful when following up with HR by email.

ANONYMOUS · UNFILTERED

What do employees actually say about Mission?

Real rants from real employees. Read before you apply.

Read Company Rants →