Clinical Contract Associate Jobs

3+ years of clinical data management experience in pharmaceutical, medical device/diagnostic company or CRO

Bachelor’s degree or equivalent combination of education/experience in science or health-related field

Excellent organizational, written, and verbal communication skills

Experience with oncology trials and biomarker studies

Perform routine and focused data cleaning activities in support of clinical data analysis milestones

Review reports on the life-cycle of clinical study samples from collection to shipping, processing, storage and analysis

The position requires a Bachelor’s Degree or equivalent experience.

Experience and familiarity with provider agreements and contracts is preferred.

Excellent interpersonal skills are necessary to develop strong working relationships with internal and external contacts.

Requires excellent diplomacy, oral and written communication skills as well as the ability to coordinate efforts among various departments at Point32Health.

Must be able to work under normal office conditions and work from home as required.

Key Responsibilities/Duties – what you will be doing

Excellent organizational skills and time management skills.

Demonstrate effective project management skills

Knowledge of global standards related to clinical data management activities.

Case report forms, edit check specifications, Data Management Plan, Data Review Plan, CRF Completion Guidelines, and other study-specific plans as required

Development and management of patient profiles for clinical review and data cleaning

Manage and store data transfers from 3rd party vendors

Assist with essential documents collection, review and archiving (TMF management)

Provide project management support for PTX project team, including vendor oversight

Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports

Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines

Assist in the review and /or development of clinical trial documents such as study plans and training materials

Participate in and assist with facilitation of project team meetings

Experience maintaining a lab notebook and following written protocols with excellent problem-solving skills.

Learn about clinical bioanalytic regulation requirements.

BS/MS in with 1+ years experience in a research setting.

Must have experience with PCR

Must have knowledge of flow cytometry, MSD, and enzymatic assays

Experience with histology is a plus

Manages, tracks, and monitors the electronic signature and contract management system uploading processes across the group

Schedules and coordinates meetings, helps prepare agendas, presentation material, and minutes for specified meetings

Compiles and collates data for assessments and the development of intelligence dashboards

Ensures scheduled SB&C reports are received, complete, and accurate

Assists Site Budgets Leads (SBLs) with investigator grant, site-facing budget, budget escalation trackers, and other deliverables

Assist Site Contracts Leads (SCLs) with letters, contract amendments, and other documents

Conduct research to support those ideas - eg tax writeoffs, details on structuring companies, budgeting, wealth management, retirement, incorporation

Exciting benefits & perks that we offer:

Come up with ideas for video shorts around helping creators figure out their finances

See the General Finance column of content listed here: https://www.notion.so/trykarat/d44135793ea14962b194c21144fd3a23?v=2b866d67e92246ddbd220d83425b3a36

Excellent writing and editing skills.

Experience creating content in long-form and short-form clips.

· Prepares and attends assessment visits with less experienced CRAs, as required.

· Sound knowledge of medical terminology.

· Excellent communication in English in both written and verbal skills.

· Excellent interpersonal and organizational skills.

· Ability to manage more than 1 study simultaneously.

· Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

The position requires a Bachelor’s Degree or equivalent experience.

Experience and familiarity with provider agreements and contracts is preferred.

Excellent interpersonal skills are necessary to develop strong working relationships with internal and external contacts.

Requires excellent diplomacy, oral and written communication skills as well as the ability to coordinate efforts among various departments at Point32Health

Must be able to work under normal office conditions and work from home as required.

Key Responsibilities/Duties – What You Will Be Doing

Support administration activities of clinical systems (e.g., User Management).

Experience in developing business specifications/requirements and user acceptance testing for computer systems.

Background of SAS programming or Data Management for clinical trials preferred

Good organization skills, ability to manage multiple tasks.

Work with end users and SMEs to define clinical data visualization business requirements and data elements

Experience with Tibco Spotfire (dashboard, visualization & report development) or other data review tools.

Work with attorneys within the Office of the General Counsel to finalize contract documents and project setup requirements.

Manages and archives legal documentation.

Requires a University Degree and minimum 2-4 years of work experience.

Excellent communication and organizational skills

Strong interpersonal skills and ability to work with team members and business leaders.

Responsible for non-attorney support of legal operations.

Contract Operational and Financial Management (strategic suppliers)

The only company to be recognized by KLAS twice for Overall Healthcare Management Consulting

History of sourcing and negotiating agreements within the Clinical Sourcing Category

Health, dental, vision, life and disability insurance

Participation in Premier’s employee incentive plans

Tuition reimbursement and professional development opportunities

5 years of specific RFI, RFP, contracting and/ or budget management experience

• Other duties as assigned by management.

• Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

(Required) Bachelor's Degree in Business / Finance or industry related field

(Preferred) Master’s Degree in Business / Finance or industry related field

5 years of contracting drafting, negotiating, and finalizing experience within Diagnostics and/ or Pharmaceutical industry

5 Years of specific RFI,RFP, Contracting and or Budget Management experience.

Note, manager prefers Local candidates, but will accept Remote candidates.

• Other duties as assigned by management.

• Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

(Required) Bachelor's Degree in Business / Finance or industry related field

(Preferred) Master's Degree in Business / Finance or industry related field

Other duties as assigned by management.

Bachelor's Degree in Business / Finance or industry related field

Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.

Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.

Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO’s, and report spend as necessary.

Minimum of 5+ years project management experience within CRO setting

Establish team roles and responsibilities and Provide clear direction to internal team and vendors to ensure study success

Manage protocol and ICF development as applicable.

Manage all study specific vendors contracts as applicable (per project scope and company contract scope)

Manage study-related vendor deliverables per SOW and study timelines

Communicate / escalates project risks to Project Director and/or direct report (line manager) as appropriate

Experience with COUPA business spend management software a plus

Demonstrated ability in identifying areas of improvement and optimization including ideas for change management

Excellent negotiation skills with the ability to understand, identify and explain contractual risk to varying stakeholders

Excellent written and verbal communication skills and ability to be clear and concise in a variety of communication settings

Develop, implement, and maintain contract tracking dashboard that supports relevant organization budget forecasting needs

Proactively identify and explain potential contract engagement risks to LOB and external contracting entities and propose effective solutions for mitigation

Strong organization and time management skills with ability to multi-task while remaining detail-oriented in a highly time sensitive environment.

Outstanding verbal and written skills proven in either a legal, University or academic medical center setting are required.

Knowledge of contract law, legal terms and conditions, and FAR and OMB Circulars related to sponsored research is preferred.

Prepares, negotiates, executes and distributes outgoing contracts, subcontracts and other agreements. Enters agreement status data into tracking system. (essential)

Identifies and mitigates regulatory compliance, legal, intellectual property, and other risks. (essential)

Works with other Research & Academic Affairs divisions as a resource for input and information as needed. (essential)

Support the management of eTMF documentation issues throughout the lifecycle of a study

Proactive management of clinical documentation and trackers

Experience working with documents at study start-up, during study conduct and close-out will be required

Experience in handling TMF documents during a regulatory inspection will be a plus.

Proactive and smart organizational skills

Excellent documentation skills and detail-orientation