Clinical Project Manager - #1467


Location:  Montgomery County Maryland


          *We offer a $1000 reward for successful referrals.  Contact us for details

          *We are conducting this search on an exclusive retained search basis

          *If relocation is necessary, assistance will be provided

          *Your start date can be in January if necessary
 

Note:  We are also seeking candidates for a Head, Clinical Operations position with the same organization.   The Job description may be found by going to:  OncologySearch.com/1468
 
 
POSITION SUMMARY
 

Our client company is a well-established clinical-stage T-cell focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases.   They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T.   They are well-funded and rapidly expanding.   We are assisting them in identifying qualified candidates for a Clinical Project Manager position on an exclusive, retained search, basis.

 

Responsibilities

  • Lead and manage large, complex trials and/or multiple smaller trials to deliver positive patient and investigator site experiences and high-quality data

  • Partner with other organizations to oversee and actively participate in Site Initiation Visits (SIVs), Investigator Calls, and Investigator Meetings

  • Be accountable for enrollment strategy

  • Be accountable for trial documentation and ensuring inspection readiness of the respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g. for high-risk areas/hot topics).

  • Lead vendor (including CRO) qualification process, selection, and oversight

  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Company standards of operation in the conduct of clinical trials.

  • Works closely with Clinical Scientist/Clinical Lead and other cross-functional team members to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), etc.

  • Responsible for management of data management and clinical operations teams in review of clinical data including providing guidance on issues/queries as needed and implementing risk management concepts as appropriate.

  • Oversee/be responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory document/packages

  • Conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs, and protocol as needed

  • Create, manage, and report timelines for milestone and deliverables

  • Other tasks assigned by the Chief Executive Officer (CEO) or Chief Medical Officer (CMO)

Qualifications:

  • Experience in management of Oncology trials or pediatric trials preferred but not required

  • Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)

  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)

  • Experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)

  • Fluency in study phases and demonstrable knowledge of how they apply to clinical development

  • Strong working knowledge of ICH Good Clinical Practice guidelines

  • Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)

  • Able to handle multiple tasks and deadlines

  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

  • Able to identify issues and take appropriate actions

  • Highly effective verbal and written communication skills

  • Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems

  • Experience in management of Oncology trials or pediatric trials preferred

  • Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)

  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)

  • At least 1-2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)

  • Fluency in study phases and demonstrable knowledge of how they apply to clinical development

  • Strong working knowledge of ICH Good Clinical Practice guidelines

  • Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)

  • Able to handle multiple tasks and deadlines

  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

  • Able to identify issues and take appropriate actions

  • Highly effective verbal and written communication skills

  • Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems
     

Location: 

Montgomery County Maryland

Benefits

Benefits include but not limited to:  Health insurance (medical paid 100% by company), dental and vision), life insurance, and 401(k) with 1:1 matching up to 3% of the salary and 1:0.5 up to the next 2%.

Interested or have questions?

Please contact Steve Collins via email (Steve@OncologySearch.com) or phone (see contact information below).  Should you wish to schedule a conversation with Steve, please visit his call scheduler at:  https://calendly.com/steve4/call


Wish to make a confidential referral for this position or our recruiting services? (we offer a $1000 reward for each successful referral.   Contact us for details) 

There are two methods to make a referral;

  • Email us and provide contact information for the person you would like us to contact.  Your name will not be revealed without our receiving your approval in advance.

  • Provide our information (i.e. name, website, email address) to the person whom you feel may have an interest.   Please ask that person to mention your name when they contact us.

Disclaimer:      

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

____________________________________________________________________________________

 

Next Step Options:
 

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

Link:    Return top of this page

shutterstock_1042918741
IMAGE - Cancer Research
Immunotherapy word cloud concept
Clinical trial word cloud concept
Man having an interview with manager and partner employment job candidate hiring
Cas9 system for editing, regulating and targeting genomes (biotechnology and genetic engineering) wo
Business - young man in job interview for hiring, welcomes, Boss or Senior and h
Scientist
Female Researcher Using Microscope.jpg
Chemistry concept. Lab Collage.jpg
Diagram of Drug Development Process
Two business colleagues shaking hands during meeting.jpg

© 2020, clbg web design