CyberCoders Senior Clinical Program Manager - Minimal Travel in Waltham, Massachusetts

Senior Clinical Program Manager - Minimal Travel Senior Clinical Program Manager - Minimal Travel - Skills Required - CTM, Clinical, Sponsor- initiated trials, TMF

On-site, permanent job opportunity with a public clinical-stage biotech company in the Greater Boston Area who has <75 employees (10 on our clinical team). They are seeking a permanent / direct-hire Senior Clinical Program Manager with experience in phase III trials, ideally global trials. If this is you, please read on!

--Please note: This is an on-site position with potential for some flexibility to work from home no more than one day per week.--

Top Reasons to Work with Us

We have a great company culture and a robust pipeline that includes two different indications entering phase III trials and multiple early- to mid-stage trials!

What's In It for You

  • Relocation Assistance

  • Minimal Travel

  • Competitive Salary

  • Stock Options

  • Great Benefits (Medical, Dental, Vision etc.)

  • Generous PTO/Vacation

  • Seminars, Training and Professional Development

  • Advancement Opportunities

  • Paid Holidays

  • Direct Deposit

What You Need for this Position

  • BS degree in a scientific discipline

  • 5+ years of clinical research experience in the pharmaceutical industry and/or CRO.

  • MS Office

  • Strong understanding of regulatory requirements (GCP, ICH, GMP, and regulatory guidelines)

What You Will Be Doing

Develop and oversee project schedule

Create spreadsheets on Excel for clinical budgets and timelines, ensuring the trial is cost effective and time-sensitive

Review clinical protocols, CRF's, study reports, and informed consent forms

Negotiate contracts and budgets with external clinical sites

Heading up study start-up activities including work orders

Participate in training internal and external resources

Prepare and manage protocol amendments

Lead internal Project Review meetings

Create and monitor required project plans

Adhere to SOPs, and ensure that others do as well

Maintain compliance with GCP, ICH, GMP, and regulatory guidelines

Participate in vendor audits, initiate and implement corrective actions with results

Creating IBs, INDs, study document filings, etc.

Manage eTMF / IVRS

Other related duties as assigned

Don't miss out, apply today!

--Please note: This is an on-site position with potential for some flexibility to work from home no more than one day per week.--

Key words: Clinical Trial Manager, Clinical Study Manager, Clinical Project Manager, Clinical Program Manager, CPM, CTM, Phase III, phase 3, phase three, sponsor, investigator

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Senior Clinical Program Manager - Minimal Travel MA-Waltham NN1-1469727