Clinical Study Manager

  • location: Collegeville, PA
  • type: Contract
  • salary: $53.13 - $62.51 per hour
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job description

Clinical Study Manager

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!

 
location: Collegeville, Pennsylvania
job type: Contract
salary: $53.13 - 62.51 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
- Accountable to ensure all relevant studies follow SOPs and GCP.

- With direction, matrix with key study conduct partners.

- Assist with maintaining relationships and monitor performance of CRO's and other vendors.

- With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.

- Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.

- Manage sites/countries transitioning from study to commercial supplies either via CROs or via LOCs.

- Manage study budgets.

- Provide oversight of the study eTMF.

- Escalate issues as needed to the Clinical Investigational Lead/medical monitor.

- Provide input into identifying implications of study progress upon overall timeline goals conduct plans.

- With oversight manage study start-up, conduct and close-out.

- Assist in the management of CRO's or other outsourcing partners as appropriate.

- Provide input into content and execution of investigator meetings / may present selected topics.

- Provide input into study plans.

- Provide input into development of CRF.

- Provide input into site selection with coordinated input.

- Aptitude for clinical systems, can do attitude, ability to work across projects/studies.

- Senior stakeholder management and collaboration with partners.

 
qualifications:
- Bachelor's Degree

- Must have between 6 months to 5 years' experience in operational delivery or similar position

 
skills: CDASH
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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