Clinical Trials Manager

**Description**:
Actalent is a global talent solutions company with a strong presence in engineering and clinical services. We are looking to grow our clinical/sciences team by bringing on a project manager/clinical trials manager who will initially support a project with a major client in the biopharmaceuticals industry. This person can sit anywhere in Canada and will be working remotely.

The project manager will be accountable for executing complex clinical trials on-time and within budget in a highly dynamic and complex global environment. This role interacts significantly with internal and external functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals. The position plays a key role in supporting the Clinical operation team in achieving its organizational goals. They will be overseeing a fully outsourced CRO program. The therapeutic area is a Vaccine and they will be working with Asia Pacific and Latin America time zones and sites. This role involves project management with oversight to achieve project timelines and budgets, but does not include having any direct reports. This is a 100% remote position. Actalent is welcome to all applicants and encouraged incorporated consultants to apply.
- Collaborate with the Clinical Study Management(CSM) team to create and maintain study timelines, risk registry and operational logistics and assess study progress to ensure all stakeholders are informed and aligned on trial deliverables.
- Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met..
- Responsible for overseeing the CSM group as they execute Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management, manage internal and external expectations and deliverables through communication and influence.
- Drive timelines/budgets in team meetings
- Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
- For government funded studies, collaborates with government agency, contracts group and external vendors to adhere to agency requirements.
- Contribute to strategic activities related to regulatory intelligence and change management.
- Assure CSM appropriate oversight for collection and tracking clinical samples from clinical sites to central labs and vendors
- Submit recommendations for study budget, forecast, reconciliations and task order changes
- Acts as clinical representative at regulatory inspections
- Model emergent core values and support overall organizational objectives. Support junior clinical trial team members in their career development, either directly or indirectly

**Skills**:
clinical trials vendor management, clinical research, clinical trial management, clinical project management, clinical study, vaccine studies, therapeutics

**Additional Skills & Qualifications**:

- The completion of a bachelor’s degree in life sciences, accompanied by over seven years’ relevant experience, or an equivalent combination of education and experience.
- Over five years of clinical trial monitoring experience
- Experience overseeing Clinical Research Associates
- Knowledgeable in Global requirements for study implementation. Experience working with APAC and LATAM regions.
- Has the ability to deal with multiple competing timelines and assignments, prioritizing successfully.
- Ability to influence without authority with internal and external stakeholders.
- Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
- Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders.
- Advanced computer skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook).
- Prior experience with eTMF, CTMS and EDC systems preferred.
- Travel may be required, predominantly in the United States and/or Canada but may include international travel.

**Job Types**: Full-time, Permanent

**Salary**: $80.00-$120.00 per hour

**Benefits**:

- Casual dress
- Company events
- Dental care
- Discounted or free food
- Employee assistance program
- Extended health care
- Flexible schedule
- On-site parking
- Paid time off
- Vision care
- Work from home

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- clinical study management: 5 years (preferred)
- Project management: 5 years (preferred)
- Vendor management: 5 years (preferred)
- APAC or LATAM region: 2 years (preferred)